BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets

BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets
U.S. Approvals, 2002-present

New!

"FDA Biopharmaceutical Product Approvals and Trends in 2012," BioProcess International, vol. 11, no. 3, March 2013, pp. 18-27.

See also Analysis of 2012 Approvals (earlier Web version of this article) (and prior Analysis of 2011 Approvals; Analysis of 2010 Approvals; Analysis of 2009 Approvals; FDA Approvals - Review 1981-2007, Editorial/Analysis, the associated article published in Genetic Engineering & Biotechnology News (GEN) and 2008 approvals analysis update).

This is a list of new full FDA approvals for biopharmaceutical products (unless otherwise noted).

[Caution, approvals may not mean what you presume they do! Granting of full approval, particularly for products approved as biologics, does not always mean that the products or their active agents are new or that their manufacture or formulation has been significantly modified, just that a new/full application was filed and granted (with something changed). Full approvals are sometimes granted for already-marketed products for new indications and manufacturing-related changes that traditionally have been handled by supplemental approvals (while to a lesser extent, the converse also occurs, with clearly new and distinct products approved through sBLAs).
For further information about basic definitions, such as "What is a biopharmaceutical?," visit www.biopharmacopeia.com.

2013

Influenza vaccine, quadrivalent/Sanofi [Fluzone Quadrivalent] granted on 6/10/2013 to Sanofi for influenza prophylaxis
This is the second injectable 4-antigen/quadarivelent influenza vaccine. Despite obviously being a distinct and unique new product, in many respects, this was apparently approved through a supplemental BLA, so many may not consider it a new product, just a comparable follow-on modified version of Fluzone. On the other hand, this 4-component vaccine, containing a new 4th component antigen, presumably would not even qualify as being biosimilar to the prior 3-component vaccine, so how it could receive approval through a supplemental BLA as being the 'same' as (i.e., comparable to) the prior vaccine, rather than being both physcially different and, presumably, a clinically better new product requiring full BLA approval? This is just one of many paradoxes and inconsistencies one encounters with biopharmaceutical approvals (yet another reason you need to subscribe to the database).
Prothrombin Complex/CSL [Prothrombin Complex Concentrate (Human) - Kcentra] granted on 4/29/2013 to CSL Behring GmbH for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.
Botulism Antitoxin/A-G [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine); Clostridium botulinum toxin immune globulin, equine] granted on 3/23/2013 to Cangene Corp. for treatment of botulism following documented or suspected exposure to botulinum neurotoxin
HER2 receptor Mab-DM1, rDNA [ado-trastuzumab emtansine - Kadcyla; trastuzumab emtansine; trastuzumab-DM1; T-DM1; trastuzumab-MCC-DM1; herceptin-DM1 conjuagate] granted on 2/22/2013 to Genentech/Roche for treatment of HER2-positive metastatic breast cancer (mBC)
apolipoprotein B, antisense [mipomersen - Kynamro; ISIS 301012] granted on 1/17/2013 to Isis Pharmaceuticals and Genzyme/Sanofi for use as an adjunct to lipid-lowering drugs and diet to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (TC), and non-high-density lipoprotein-cholesterol (non HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH)
[Note, as a fully-synthetic antisense phosphorothioate, this drug is considered a borderline biopharmaceutical].
Plasma SD/Octapharma [Octaplas - Plasma, solvent-detergent inactivated] granted on 1/17/2013 to Octapharma AG for needed replacement of clotting proteins (coagulation factors)
Influenza vaccine, rHA, rDNA [Influenza Vaccine, Purified Recombinant Influenza Hemagglutinin - FluBlok; influenza hemagglutinin vaccine, insect cell-cultured, recombinant] granted on 1/17/2013 to Protein Sciences Corp., with marketing by Emergent Biosolutions, Inc., for prevention of influenza in persons 18-49 years old
[the first modern recombinant (vs. natural recombinant FluMist) influenza vaccine, the first single-antigen influenza vaccine]

2012

glucagon-like peptide 2, rDNA [teduglutide [rDNA origin] - GATTEX] granted on 12/21/2012 to NPS Pharmaceutical for treatment of adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition)
Immune Globulin (IGIV)/Biotest [Immune Globulin Intravenous (Human) - Bivigam] granted on 12/20/2012 to Biotest Pharmaceuticals Corp. for treatment of primary immune deficiency disorders (PIDD).
Varicella-Zoster Immune Globulin/Cangene [Varicella-Zoster Immune Globulin (Human) - VariZIG; VZVIG] granted on 12/19/2012 to Cangene Corp. for post-exposure prophylaxis of varicella in high risk individuals to reduce the severity of varicella
Fluarix Quadravalent [Influenza Virus Vaccine - Fluarix Quadravalent] granted on 12/17/2012 to GlaxoSmithKline (GSK), for prevention of disease caused by the four seasonal influenza (flu) virus subtypes A and type B strains represented by antigens in the vaccine
This is the first injectable 4-antigen/quadarivelent influenza vaccine. See the first 4-antigen/quadarivelent influenza vaccine below, which happens to be an intranasal vaccine, with its approval earlier in 2012. Despite obviously being a distinct and unique new product, in many respects, this was approved through a supplemental BLA, so many may not consider it a new product, just a comparable follow-on modified version of Fluarix. On the other hand, this 4-component vaccine, containing a new 4th component antigen, presumably would not even qualify as being biosimilar to the prior 3-component vaccine, so how it could receive approval through a supplemental BLA as being the 'same' as (i.e., comparable to) the prior vaccine, rather than being a physcially different, presumably clinicly better new product requiring full BLA approval? This is just one of many paradoxes and inconsistencies one encounters with biopharmaceutical approvals (yet another reason you need to subscribe to the database).
Anthrax Mab, rDNA/HGSI [raxibacumab - ABthrax; Bacillus anthracis protective antigen human monoclonal antibody, recombinant] granted on 12/14/2012 to Human Genome Sciences Inc., a subsidiary of GlaxoSmithKline (GSK), for treatment of inhalational anthrax and prevention of inhalational anthrax when alternative therapies are not available or not appropriate.
Fibrin Sealant Patch/J&J [Fibrin Sealant Patch-Human Fibrinogen and Human Thrombin - EVARREST Fibrin Sealant Patch] granted on 12/7/2012 to Ethicon Biosurgery, Johnson & Johnson (J&J), with manufacture by Omrix Biopharmaceuticals Ltd. (Israel) for use as an aid in stopping problematic bleeding during surgery
Influenza vaccine, MDCK cultured/Novartis [Flucelvax; Optaflu; Influenza virus vaccine, inactivated] granted on 11/20/2012 to Novartis for prevention of seasonal influenza in people ages 18 years and older [the first cell cultured influenza vaccine in the U.S.]
Microplasmin, rDNA [Ocriplasmin - Jetrea] granted on 10/18/2012 to ThromboGenics for treatment of symptomatic vitreomacular adhesion
G-CSF, rDNA/Teva [filgrastim; same active agent as Neupogen and TevaGrastin, approved as a biosimilar of Neupogen in the EU] Full BLA granted on 8/30/2012 to Sicor Biotech (Teva Pharmaceuticals) to reduce the duration of severe neutropenia in patients with certain types of cancer (non-myeloid malignancies) receiving chemotherapy that affects the bone marrow.
So far, there is no indication of why, how, etc. FDA is using the "tbo" prefix and not using the USAN name (filgrastim).
VEGF Trap, rDNA [ziv-aflibercept - Zaltrap] granted on 8/3/2012 to Sanofi (with Regeneron) for use in combination with 5-flourouracil, leucovorin, irinotecan-(FOLFIRI) for treatment of metastatic colorectal cancer (mCRC) resistant to or having progressed following an oxaliplatin-containing regimen
Note: Zaltrap received a full BLA, but its active agent is absolutely the same as in Eylea (approved in late 2011) also developed and manufactured by Regeneron, with Zaltrap approved for a different indication and marketed by different company. So far, there is no indication of why, how, etc. FDA is using the "ziv" prefix and not using the USAN name (afibercept).
MenC-Hib vaccine [Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine - MenHibrix] granted on 6/14/2012 toGlaxoSmithKline for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (a combination of prior-approved vaccines)
HER2 receptor Mab, rDNA/2C4 [pertuzumab - Perjeta; Omnitarg; 2C4] granted on 6/8/2012 to Genentech/Roche for use combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the first-line treatment of HER2-positive metastatic breast cancer
Glucocerebrosidase, rDNA/Protalix [taliglucerase alfa - Elelyso; Uplyso; beta-glucocerebrosidase, recombinant (carrot expressed); prGCD] granted on 5/1/2012 to Protalix BioTherapeutics Inc. and Pfizer (the BLA holder) for treatment of Gaucher disease [Could be considered a biobetter version of Cerezyme from Genzyme/Sanofi]
Human cells, autologous/bovine collagen substrate [Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen - GINTUIT] granted on 3/9/2012 to Organogenesis Inc. for topical application to a surgically created vascular wound bed in the treatment of mucogingival (gums; oral tissue) conditions [first cell-based product for an oral tissue application]
Pancreatic enzymes [pancrelipase - Ultresa; Viokase] granted on 3/1/2012 to Aptalis Pharma for treatment of orphan pancreatic insufficiency indications [First full approval for a long-marketed, grandfathered drug product].
Influenza vaccine, live intranasal quadravalent [FluMist Quadrivalent; Influenza Vaccine Live, Intranasal] sBLA granted on 2/29/2012 to MedImmune (AstraZeneca) for prevention of seasonal influenza
This is the first 4-antigen/quadarivelent influenza vaccine. Yet, in many respects, despite being a distinct and unique new product, this was approved through a supplemental BLA. The 4-component vaccine, containing a new 4th component antigen component, would presumably not even qualify as being biosimilar to the prior 3-component vaccine (physically different, clinically better), so how it could receive approval through a supplemental BLA as being the 'same' as (i.e., comparable to) the prior vaccine, rather than requiring full BLA approval? This is just one of many paradoxes and inconsistencies one encounters with biopharmaceutical approvals (yet another reason to subscribe to the database).
Carboxypeptidase, rDNA - [Glucarpidase - Voraxaze; CPG2; carboxypeptidase G2, recombinant] granted on 1/18/2012 to BTG plc (formerly Protherics) for treatment of methotrexate toxicity

2011

VEGF Trap, rDNA - [Aflibercept - Eylea; VEGF Trap-Eye] granted on 11/18/2011 to Regeneron Pharmaceuticals (with international marketing by Bayer) for treatment of wet (neovascular) age-related macular degeneration (AMD)
Asparaginase/Erwinia - [Erwinaze - asparaginase Erwinia chrysanthemi; Erwinase; L-asparagine aminohydrolase; L-asparaginase] granted on 11/18/2011 to EUSA Pharma Inc. for treatment of acute lymphoblastic leukemia (ALL)
cord blood stem cells - [HEMACORD; Hematopoietic progenitor cells-cord (HPC-C) cell therapy] approval granted on 11/10/2011 to the New York Blood Center, Inc. for use in hematopoietic stem cell transplantation procedures in patients with disorders affecting the hematopoietic (blood forming) system.
CD30 mAb-monomethyl auristatin E - [Adcetris; brentuximab vedotin; CD30 mAb-cytotoxin conjugate] accelerated approval with orphan status granted on 8/19/2011 to Seattle Genetics, Inc. for treatment of Hodgkin lymphoma; currently the only immunotoxin in the U.S. market
Centruroides (Scorpion) Immune F(ab)2 (Equine) Injection [Anascorp] granted on 8/3/2011 to Rare Disease Therapeutics Inc. for treatment of scorpion stings, with manufacture by Instituto Bioclon, S.A. (Mexico) [Is this the first Latin American-manufactured complex biologic to receive full BLA approval?]
Fibroblasts, autologous [azfibrocel-T - laViv; Isolagen Therapy] granted on 6/22/2011 to Fibrocell Science, Inc. for treatment of the appearance of nasolabial fold wrinkles (smile lines)
CTLA4-Ig, rDNA [belatacept - Nulojix; BMS-224818; CTLA4-Ig mutant; cytotoxic T-lymphocyte- associated antigen 4 (CTLA-4)--Immunoglobulin G1 fragment fusion protein, recombinant] granted on 6/15/2011 to Bristol-Myers Squibb (BMS) for prevention of acute rejection in adult kidney transplant patients
Albumin, human - [Kedbumin] granted on 6/3/2011 to Kedrion, S.p.A. for treatment of hypovolemic shock, hypoalbuminemia, prevention of central volume depletion after paracentesis due to cirrhotic ascites, Ovarian Hyperstimulation Syndrome (OHSS), Adult Respiratory Distress Syndrome (ARDS), burns, hemodialysis patients undergoing long term dialysis, patients who cannot tolerate substantial volumes of salt solution and as a priming solution for cardiopulmonary bypass
CTLA-4 Mab, rDNA/Medarex [Yervoy; Ipilimumab; MDX-010; cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody, recombinant] granted on 3/25/2011 to Bristol-Myers Squibb (BMS) for treatment of late-stage melanoma
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral [composed of Adenovirus Vaccine, type 4 and Adenovirus Vaccine, type 7] granted on 3/16/2011 to Teva Pharmaceuticals for immunization of U.S. military personnel only
B-cell-activating factor Mab, rDNA: [belimumab - Benlysta; LymphoStat-B] granted on 3/9/2011 to Human Genome Sciences, Inc. (for marketing along with GlaxoSmithKline/GSK) for treatment of treatment of adults with active, autoantibody-positive systemic lupus erythematosus
Factor XIII, human: [Cortifact] granted on 2/17/2011 to CSL Behring for treatment of Factor XIII deficiency

2010

Urate oxidase, rDNA, PEG-: [Pegloticase - Krystexxa; Puricase; PEG-uricase; pig-baboon uric acid oxidase, recombinant, pegylated] granted on 9/14/2010 to Savient Pharmaceuticals for treatment of chronic refractory gout.
Botulinum Toxin A/Merz: [Xeomin; Clostridium botulinum toxin type A; NT 201] granted on 7/30/2010 to Merz Pharmaceuticals for treatment of adults with cervical dystonia or blepharospasm.
Antitrypsin, alpha-1/Kamada: [alpha-1-Proteinase Inhibitor (Human) - Glassia; Respira; alpha-1 antitrypsin; AAT; A1P1] granted on 7/1/2010 to Kamada Ltd. for treatment of alpha1-antitrypsin deficiency.
RANKL Mab, rDNA: [Denosumab - Prolia; AMG 531; AMG 162. receptor activator of nuclear factor kappa B ligand (RANKL) monoclonal antibody, recombinant] granted on 6/1/2010 to Amgen Inc. for treatment of postmenopausal women with osteoporosis at high risk for fracture
Glucosidase, rDNA/Lumizyme: [Alglucosidase alfa - Lumizyme; alpha glucosidase; glucosidase alpha; rhGAA]] granted on 5/25/2010 to Genzyme Corp. for treatment of Pompe disease
Prostate Cancer Cellular Vaccine (rDNA): [Sipuleucel-T - Provenge - prostatic acid phosphatase (PAP)--granulocyte macrophage-colony stimulating factor (GM-CSF) recombinant fusion protein (PAP-GM-CSF; PA2024)-sensitized autologous antigen-presenting cells (APCs); PA2024-loaded APCs; APC8015] granted on 4/29/2010 to Dendreon Corp. for treatment of asymptomatic or minimally symptomatic metastatic prostate cancer resistant to standard hormone treatment
Pancreatic Enzymes/J&J: [Pancreaze; Pancreatic Enzyme Product] NDA granted on 4/12/2010 to Johnson & Johnson (J&J) for treatment of pancreatic insufficiency
Fibrin Sealant/TachoSil [Absorbable Fibrin Sealant Patch] granted on 4/2/20101 to Nycomed Austria GmbH for use as an adjunct to hemostasis in cardiovascular surgery when control of bleeding by standard surgical techniques, such as suture, ligature or cautery, is ineffective or impractical.
Immune globulin (SCIG) [Immune Globulin Subcutaneous (Human) - Hizentra; (Vivaglobin is an older, lower-concentration product)] granted on 3/4/2010 to CSL Behring for treatment of primary immunodeficiency
Glucocerebrosidase, rDNA/Shire [velaglucerase alfa; ceramidase, glucosyl-(human HT-1080 cell); human glucosylceramidase (EC 3.2.1.45 or beta-glucocerebrosidase), glycoform alpha; beta-glucocerebrosidase] granted on 2/26/2010 to Shire Pharmaceutical for treatment of Gaucher Disease
Pneumococcal Vaccine(13)-CRM197 [Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) - Prevnar 13; Prevenar 13; Streptococcus pnuemoniae capsular antigen-Diphtheria CRM197 protein conjugate vaccine; PCV13] granted on 2/24/2010 to Pfizer (developed by Wyeth) for prevention of Streptococcus pnuemoniae-related disease
Meningococcal Conjugates Vaccine/Novartis [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine - Menveo; MenACWY-CRM] granted on 2/19/2010 to Novartis prophylaxis against invasive meningococcal disease
Collagenase [clostridial collagenase for injection - Xiaflex] granted on 2/3/2010 to Auxilium Pharmaceuticals Inc. for the treatment of treatment of Dupuytren's disease
Glucagon-like peptide-1, rDNA [liraglutide - Victoza; Arg34-GLP-1[7-37]; GLP-1 [recombinant]; NN-2211] granted on 1/25/2010 to Novo Nordisk for the treatment of type 2 diabetes
Interleukin-6 receptor Mab, rDNA [tocilizumab; Actemra; RoActemra; interleukin-6 receptor monoclonal antibody, recombinant; IL-6r Mab] granted on 1/8/2010 to Amgen for the treatment of rheumatoid arthritis (RA)

2009

Influenza Vaccine, high dose [Fluzone High-Dose] granted on 12/23/2009 to Sanofi Pasteur for the the prevention of influenza in persons 65 years of age of older; full BLA granted, but this is simply a higher-dose (60 �g vs. 15 �g of each influenza strain HA antigen) formulation of Fluzone, the influenza vaccine most used in the U.S.; [Should this be considered a new product or not? You decide. It's the same old product, at a different concentration, but with a new full approval and a new but much the same indications with these a subset of those approved for use of regular Fluzone].

vWF/Factor VIII Complex [Wilate] granted on 12/4/2009 to Octapharma USA, Inc. for the treatment of von Willebrand disease (VWD)

Kallikrein inhibitor, rDNA [ecallantide - Kalbitor; DX-88; kallikrein inhibitor protein, recombinant] granted on 12/1/2009 to Dyax Corp. for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older

Influenza vaccine/Novartis Italy [Agriflu] granted on 11/27/2009 to Novartis for prophylaxis against H1N1 (swine flu) influenza; This (or much the same) conventional inactivated egg-cultured vaccine has long been manufactured at site in Siena, Italy, primarily for European markets.

Influenza vaccine, H1N1/GSK Canada granted on 11/10/2009 to ID Biomedical, subsidiary of GlaxoSmithKline (GSK), for prophylaxis against H1N1 (swine flu) influenza; Note, although a new and distinct product, this was approved as a supplemental BLA. [This is an H1N1 analog or biosimilar/biogeneric monovalent version of Influenza vaccine/GSK Canada (FluLaval)].

CD20 Mab, human, rDNA [ofatumumab - Arzerra; HuMax-CD20; CD20 monoclonal antibody, human, recombinant] granted on 10/26/2009 to GlaxoSmithKline (and Genmab) for the treatment for chronic lymphocytic leukaemia in patients who have not responded to Campath (alemtuzumab) or fludarabine

Antitrypsin, alpha-1/Talecris [Alpha-1-Proteinase Inhibitor (Human) - Prolastin-C; alpha1-antitrypsin] granted on 10/19/2009 to Talecris Biotherapeutics for the treatment of alpha1-antitrypsin (AAT) deficiency

HPV vaccine, rDNA/GSK [Cervarix MEDI 501; human papilloma virus (HPV) vaccine types 16 and 18 L1 virus-like particles, recombinant] granted on 10/16/2009 to GlaxoSmithKline, Inc. for prophylaxis against cervical cancer in females

C1-esterase inhibitor/CSL [Berinert P; C1INH; C1-INH; complement C1 esterase inhibitor, plasma-derived] granted on 10/09/2009 to CSL Behring LLC for the acute treatment of hereditary angioedema (HAE)

IL-12/23 p40 Mab, rDNA [ustekinumab - STELARA; CNTO 1275; interleukin-12 (IL-12) and interleukin-23 (IL-23) p40 subunit monoclonal antibody, human, recombinant] granted on 9/25/2009 to Centocor Ortho Biotech Inc. (Johnson & Johnson) for treatment of moderate to severe plaque psoriasis

Immune Globulin (IGIV)/Bio Products [Immune Globulin Intravenous (Human) - Gammaplex] granted on 9/17/2009 to Bio Products Lab. for the treatment of primary humoral immunodeficiency

Influenza vaccine, H1N1/Novartis granted on 9/15/2009 to Novartis AG for prophylaxis against H1N1 (swine flu) influenza; Note, although a new and distinct product, this was approved as a supplemental BLA

Influenza vaccine, H1N1/Sanofi granted on 9/15/2009 to Sanofi-Pasteur for prophylaxis against H1N1 (swine flu) influenza; Note, although a new and distinct product, this was approved as a supplemental BLA

Influenza vaccine, H1N1/CSL granted on 9/15/2009 to CSL Ltd. for prophylaxis against H1N1 (swine flu) influenza; Note, although a new and distinct product, this was approved as a supplemental BLA

Influenza Vaccine, live rDNA, H1N1 granted on 9/15/2009 to MedImmune (AstraZeneca) for prophylaxis against H1N1 (swine flu) influenza; Note, although a new and distinct product, this was approved as a supplemental BLA

Haemophilus b Vaccine/GSK [Hiberix; Haemophilus influenzae Type b vaccine; Hib vaccine] granted on 8/19/2009 to GlaxoSmithKline (GSK) as Hib vaccine booster dose for children 15 months through 4 years old

Interferon betaser, rDNA/Novartis [Interferon beta-1b - Extavia; 2-166-Interferon beta1 (human fibroblast reduced), 17-L-serine-; interferon betaser, recombinant; NVF233] granted on 8/15/2009 to Novartis Pharmaceuticals for multiple sclerosis indications
Note, this is simply a rebranded (relabeled) version of Betaseron from Bayer Schering. Thus, although the product received a full BLA approval, it is not a new product from an entity/composition perspective - only from strict (or contrived) approval- and commercial/sales-based perspectives. Does this product deserve 12 years of biosimilar data exclusivity? Following current legislation, which grants products exclusivity based on receiving BLA approval, this product, which is simply a relabeled version of another (an "authorized generic"), would receive exclusivlty. See www.biosimilars.com for further discussion of this and other aspects of biosimilars legislation].

Interleukin-1 Mab, rDNA [Canakinumab - Ilaris; interleukin-1 beta monoclonal antibody; ACZ885] granted on 6/17/2009 to Novartis Pharmaceuticals for treatment of Cryopyrin Associated Periodic Syndrome (CAPS)

Pancreatic Enzyme/Solvay [pancrelipase - Creon; pancreatic enzymes, porcine-derived] granted on 5/1/2009 to Solvay for treatment of exocrine pancreatic enzyme insufficiency [Note, although this is Creon's first approval, this is not a new product. This same product has long been grandfathered -- on the market for so many decades that it had never been previously required to receive formal approval].

Botulinum Toxin A/Ipsen [abobotulinumtoxinA - Dysport; Reloxin; Clostridium botulinum toxin type A] BLA granted on 4/29/2009 to Ipsen for treatment of cervical dystonia and a sBLA granted at the same time to Medicis for Reloxin (relabeled Dysport) for treatment of gabellar (frown) lines.

Golimumab [Simponi; CNTO 148; tumor necrosis factor-alpha human monoclonal antibody, recombinant] granted to Centocor Ortho Biotech Inc./Johnson & Johnson on April 24, 2009 for treatment of three types of immune dysfunction-related arthritis

Japanese Encephalitis Vaccine/Intercell - [Ixiaro; Japanese encephalitis SA14-4-2 virus vaccine; IC51] granted to Intercell Biomedical (with marketing by Novartis) on 3/30/2009 for prevention of Japanese encephalitis disease

Antithrombin III, rDNA [Antithrombin III (Human) - ATryn; rhATIII; AT-III, recombinant transgenic goat] granted to GTC Biotherapeutics, Inc. (Genzyme) on 2/6/2009 for prevention of blood clots in patients with antithrombin deficiency
Fibrinogen/CSL [Fibrinogen Concentrate (Human) - RiaSTAT; Haemocomplettan P; Factor I] granted on 1/16/2009 to CSL Behring for treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia).

2008 [Note, 3 of the 13 products listed below that received full approvals (BLA or NDA) in 2008 involve simple combination use and/or packaging of previously approved products, and are not considered by BIOPHARMA to be new, distinct/unique products. This is further discussed in the 2008 approvals analysis update. Another product, Xyntha, fallls in a grey area (is unclear whether it should be considered an updated version or a new product)]:

C1-esterase inhibitor/Sanquin [Cinryze; CetorA; C1INH; C1-INH; complement C1 esterase inhibitor, plasma-derived] granted on 10/10/2008 to Lev Pharmaceuticals for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE; C1 inhibitor deficiency)

Insulin aspart, rDNA, 50/50 mix [Novolog Mix 50/50; Biophasic Insulin Aspart 50/50] granted on 8/26/2008 to Novo Nordisk for treatment of diabetes [A simple 50/50 mixture of previously-approved Novolog (insulin aspart, rDNA) and regular recombinant insulin, despite receiving a full NDA, BIOPHARMA does not consider this to be a new/novel product. If this were considered as a distinct/unique product, every other combination of insulin variants would need to similarly be treated as a different, unique/distinct product].

Thrombopoietin peptibody, rDNA [romiplostim - NPLATE; AMG-531; Amgen Megakaryopoiesis Protein 531; thrombopoietin mimetic peptibody, recombinant] granted on 8/22/2008 to Amgen for treatment of adults with chronic immune thrombocytopenic purpura (ITP)

DTaP-Hib-Polio Vaccine/Sanofi [Pentacel; ActHIB Reconstituted with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Poliovirus Vaccine Inactivated; ActHIB plus Quadracel; Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed plus Haemophilus influenzae type b (Hib) vaccine plus Poliovirus Vaccine Inactivated (Human Diploid Cell)] granted on 6/20/2008 to Sanofi Pasteur [As the combination of two previously approved combination vaccines, with the two mixed before administration, BIOPHARMA does not consider this to be a new, distinct/unique product].

Interferon alfa-2b, rDNA, PEG- plus Ribavirin [PEGPAK; combination packaging of PEG-Intron and ribavirin] granted 6/13/2008 to Schering-Plough for treatment of chronic hepatitis C [As simple combined packaging and use of already-approved PEG-Intron and the drug, ribavirin, with this combination long in therapeutic use, BIOPHARMA does not consider this to be a new, distinct/unique product].

TNF Mab Fab', rDNA, PEG- [Certolizumab pegol - Cimzia; CDP 870; tumor necrosis factor monoclonal antibody Fab fragment, recombinant--polyethylene glycol (PEG) polymer conjugate] granted on 4/23/2008 to UCB (with U.S. marketing by Bayer Schering) for treatment of refractory Crohn's disease in adults

Rotavirus Vaccine, live/GSK [Rotavirus Vaccine, Live, Oral, Monovalent - Rotarix; RIX-4414] granted on 4/4/2008 to GlaxoSmithKline (GSK) for prevention of rotavirus gastroenteritis in infants

DTaP-IPV/GSK [Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed plus Poliovirus Vaccine Inactivated (Human Diploid Cell) - Kinrix] granted on 3/24/2008 to GlaxoSmithKline for pediatric vaccination

Fibrin Sealant/Baxter [Fibrin Sealant, VH S/D 4 - Artiss; Fibrin Sealant, Vapor Heated Solvent/Detergent Treated] granted on 3/19/2008 to Baxter Healthcare for use in attaching skin grafts onto burn patients. [This appears to be a next-generation version and replacement for Tisseel Kit VH].

Interleukin-1 trap, rDNA [Arcalyst; rilonacept; IL-1 Trap, recombinant] granted on 2/27/2008 to Regeneron Pharmaceuticals Inc. for long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

Antihemophilic Factor (Recombinant), Plasma/Albumin Free [Xyntha; recombinant coagulation factor VIII; an updated version of ReFacto, now with no human or animal products used in its manufacture or formulation]; full BLA granted to Wyeth on 2/21/2008 for treatment of hemophilia A
Is this a new product or not? It all depends on how you view biopharmaceutical similarity/uniqueness/sameness and approvals. See "What is a Generic Biopharmaceutical?" and "What is a Biopharmaceutical?" and other articles at biopharmacopeia.com and biosimilars.com. With its seemingly minimal trials (abbreviated filing), similar (but different) formulation and manufacturing process and its active agent being confirmed by FDA as the same/identical rDNA human Factor VIII as in ReFacto, which this product is replacing, Xyntha exhibits many aspects of being a follow-on (biosimilar) version of ReFacto. Xyntha could also be considered the same product (not a new product), just a minor variation or new version of ReFacto, with such approvals typically (for decades) handled as supplemental approvals. Some, primarily considering that Xyntha's manufacturing processes and formulation have been changed substantially (updated to state-of-the-art), would consider this a fully new/novel/distinct product (and one fully worthy of receiving full-length data exclusivity protection from use as a reference product for biosimilar approval). [With BLAs proposed as the determinant for granting 12-14 years exclusivity to refernce (innovator) biologics, there is a major potential advantage to getting full vs. supplemental approvals wherever possible]. FDA accepts the drug substance (B-domain-deleted recombinant Factor VIII protein) in the two products to be the same (unchanged). But with no bioequivalence or other direct comparison clinical studies [and with both products' BLA approvals based on showing comparability with a full-lengh Factor VIII product], there is at best indirect demonstration of Xyntha being clinically comparable, substitutable or interchangable with ReFacto (although most physicians, pharmacists, patients, etc. will simply transition from ReFacto to Xyntha and consider them much the same). Others may ignore any consideration of the active agents and products and consider Xyntha a new/novel/unique product based solely on it having received full vs. supplemental BLA approval (although approvals/BLAs were never designed to define new products). Further confounding the situation, the product marketed as Xyntha in the U.S. received full, not supplemental, approval in the European Union under the trade name Refacto AF [animal-free], clearly presenting it as the same as the prior ReFacto, just a new variation or version, and indicative of full comparability, substitutablity and interchangability.
[Is Xyntha a new product -- a new reference product for purposes of considering biosimilars/follow-on applications -- or not? If eventual U.S. biosimilars legislation grants years of data exclusivity to new reference products, should Xyntha receive this protection or not? These are very good questions, and such issues, including related opportunities for infinite evergreening, appear not to be seriously addressed in ongoing discussions of biosimilar's legislation].

Somatropin, rDNA/Cangene [Somatropin (rDNA origin) for Injection - Accretropin] - 505(b)(2) follow-on protein NDA granted on 1/24/2008 to Cangene Corp. (marketing by Apotex) for treatment of pediatric growth failure or short stature

Thrombin, rDNA [Recothrom; Thrombin, recombinant; rhThrombin] - granted on 1/17/08 to ZymoGenetics, Inc. to help halt bleeding from small blood vessels after surgery

2007:

EPO, rDNA, PEG- [Continuous Erythropoietin Receptor Activator; Mircera; CERA; epoetin alpha (recombinant), pegylated; methoxy polyethylene glycol-epoetin beta)] - granted on 11/14/07 to Hoffmann-La Roche Inc. for treatment of anemia associated with chronic renal failure in adults [Note, product may never be launched in U.S. due to infringement of patents held by Amgen (related lawsuit nearly but not yet finally resolved)].

Skin, Cultured/Epicel [Cultured Epidermal Autograft - Epicel; Cultured Autologous Keratinocytes Service; CEA] - HDE granted on 10/29/07 to Genzyme Corp. for the treatment of life-threatening wounds resulting from severe burns.

Influenza Vaccine/CSL [Influenza Virus Vaccine, Trivalent, Types A and B - AFLURIA; Fluvax; Enzira] - granted on 9/28/07 to CSL Ltd. for prophylaxis against influenza.

Smallpox vaccine/Vero - granted on 8/31/07 to Acambis plc for prophylaxis against smallpox (in the biodefense stockpile).

Thrombin/Omrix [Evithrom] - granted on 8/27/2007 to Omrix Biopharmaceuticals for control of bleeding (inaccessible/otherwise untreatable oozing of blood and minor bleeding from capillaries and small venules)

Fibrin Sealant/Thermogenesis [CryoSeal Fibrin Sealant System; CryoSeal FS System; cryoprecipitate plus thrombin, autologous]; granted on 7/26/2007 to Thermogenesis Corp. for control of bleeding during liver surgery

Immune Globulin (IGIV), liquid/CSL [Immune Globulin Intravenous (Human), 10% Liquid - Privigen]; granted on 7/26/2007 to CSL BioPlasma Inc. for treatment of primary immunodeficiency

Influenza Vaccine, H5N1/Sanofi [Influenza Virus Vaccine, H5N1; pandemic influenza vaccine; bird flu vaccine]; granted on 4/17/2007 to Sanofi Pasteur Inc. for active immunization of adults at increased risk of exposure to the H5N1 influenza virus [for use in case of a bird flu-related influenza epidemic/pandemic]

Somatropin, rDNA/BioPartners [Somatropin (rDNA origin) for Injection - Valtropin; human growth hormone, recombinant]; granted on 4/19/2008 to Parexel, a CRO proxy for LG Life Sciences, for treatment of growth deficiencies [Incredibly, despite this being a follow-on protein, generic drug approval, not a single news report has yet to came out about this, other than Signals magazine in fall 2007)! This author noticed Valtropin's approval in mid-March 2008, so it did not make it into the approvals review. Apparently, FDA neglected to announce this approval through normal channels at the time. Was this as "stealth" follow-on protein approval?].

Protein C, plasma-derived [Ceprotin]; granted on 3/27/2007 to Baxter Healthcare for treatment of severe congenital Protein C deficiency.

Complement C5 Mab, rDNA [Eculizumab - Soliris; complement C5 monoclonal antibody, recombinant] - granted on 3/16/07 to Alexion Pharmaceuticals, Inc. for ttreatment of paroxysmal nocturnal hemoglobinuria (PNH)

Poly-4-hydroxybutyrate, rDNA [TephaFLEX Absorbable Suture; poly-4-hydroxybutyrate; P4HB; poly(4HB); PHA4400] - granted on 2/12/2007 to Tepha, Inc. for use as surgical sutures

2006:

Albumin (Human) [one of many Albumin products] - granted on 10/17/06 to Octapharma Pharmazeutika Produktionsgesm.b.H for the restoration and maintenance of circulating blood volume

Influenza vaccine/ID Biomedical [Influenza Virus Vaccine, Trivalent - FluLaval; Fluviral] granted on 10/05/06 to GlaxoSmithKline (acquired ID Biomedical) for the active immunization of adults 18 years and older against influenza.

EGF receptor Mab, human, rDNA [Panitumumab - Vectibix; ABX-EGF; epidermal growth factor receptor monoclonal antibody, human, recombinant; E7.6.3; rHuMAb-EGFr; transgenic XenoMouse-derived human EGF receptor Mab]; granted on 9/27/2006 to Amgen Inc. "for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens"

Iduronate-2-sulfatase, rDNA [Idursulfase; Elaprase; L-iduronate 2-sulfate sulfatase precursor; recombinant; I2S; chondroitinsulfatase]; granted on 7/24/2006 to Shire Pharmaceuticals Group plc (through its acquisition of Transkaryotic Therapies, Inc.) for the treatment of Hunter syndrome (mucopolysaccharidosis II; MPS II).

VEGF Mab Fab, rDNA [Lucentis; vascular endothelial growth factor monoclonal antibody fragment, recombinant] granted on 6/30/2006 to Genentech, Inc. for treatment of age-related macular degeneration

HPV vaccine, rDNA/Merck [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine;- Gardasil; human papilloma virus (HPV) types 6, 11, 16 and 18 L1 virus-like proteins (VLPs), recombinant]; granted on 6/8/2006 to Merck & Co., Inc. for vaccination in females 9-26 years of age for prevention of diseases caused by human papillomavirus (HPV) types 6, 11, 16, and 18.

Somatropin, rDNA/Sandoz [Somatropin (rDNA origin) - Omnitrope; human growth hormone, recombinant] granted on 5/30/2006 to Sandoz, Inc., a subsidiary of Novartis AG, for treatment of growth hormone deficiency.

Varicella Virus Vaccine/adult [Zoster vaccine live (Oka/Merck); Zostavax; Varicella virus vaccine for adults]; granted on 5/25/2006 to Merck & Co., Inc. for prevention of herpes zoster (shingles) in persons 60 years of age or older.

Glucosidase, rDNA [Alglucosidase alfa - Myozyme; Pompase; alpha glucosidase; glucosidase alpha (rhGAA) [recombinant]]; granted on 4/28/2006 to Genzyme Corp. for treatment of Pompe disease.

Rotavirus Vaccine, rDNA/Merck [Rotavirus Vaccine, Quintavalent - RotaTeq; WC3 pentavalent vaccine]; granted on 2/3/2006 to Merck & Co., Inc. for prevention of pediatric rotavirus gastrointestinal disease.

Hepatitis B Immune Globulin, i.m./Cangene [Hepatitis B Immune Globulin (Human); HepaGam B]; granted on 1/27/2006 to Cangene Corp. for for post-exposure propylaxis following acute exposure to hepatitis B virus.

Insulin, rDNA, inhaled/Pfizer [Exubera Insulin, recombinant powder for inhalation]; granted on 1/27/2006 to Pfizer, Inc. for the treatment of adults with type 1 and type 2 diabetes.

Immune globulin (SCIG) [Vivaglobin]; granted on 1/9/2006 to ZLB Behring for treatment of primary immunodeficiency.

2005

CTLA4-Ig, rDNA [Orencia; Abatacept; cytotoxic T-lymphocyte- associated antigen 4--Immunoglobulin G1 fragment fusion protein, recombinant; BMS-188667] granted on 12/26/2005 to Bristol-Myers Squibb Co. for second-line treatment of rheumatoid arthritis in moderate to severe adult patients.

Insulin-like Growth Factor-1/IGFBP-3, rDNA [Mecasermin rinfibate - IPLEX; SomatoKine; nsulin-like growth factor I--insulin-like growth factor-binding-3 protein complex, recombinant; IGF-1/IGFBP3 complex] granted on 12/12/2005 to Insmed Inc. for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Hyaluronidase, rDNA [Hylenex; Enhanze SC; Cumulase; Chemophase; rHuPH20; PH-20 hyaluronidase, recombinant human] approval of Hyelex (formerly Enhanze SC) granted on 12/5/2005 to Halozyme Therapeutics Inc. for marketing by Baxter for use as a "spreading agent" to enhance the delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement (hypodermoclysis).

Hyaluronidase, ovine/Primapharm [Hydase] granted on 10/25/2005 to PrimaPharm, Inc. for use as a "spreading agent" to enhance the delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement (hypodermoclysis).

PDGF, rDNA/Bone matrix [Platelet-derived growth factor (PDGF)-BB, recombinant with inorganic bone matrix; rhPDGF-BB; GEM 21S] granted on 10/21/2005 to BioMimetic Therapeutics, Inc. for marketing by Osteohealth Co. (Luitpold Pharmaceuticals, Inc., Sankyo Co., Ltd.) for the treatment of periodontal bone defects and associated gingival recession.

Measles Mumps Rubella & Varicella Vaccine [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live - ProQuad; M-M-R II plus Varivax vaccine] granted on 9/6/2005 to Merck & Co., Inc. for vaccination against measles, mumps, rubella (German measles) and varicella (chickenpox) in children 12 months to 12 years of age

Influenza Vaccine/GSK Canada [Influenza Virus Vaccine, Trivalent, Types A and B - Fluarix]; granted on 8/31/2005 to GlaxoSmithKline Biologicals for prevention of influenza

Influenza vaccine/GSK Germany [Influenza Virus Vaccine, Trivalent - Fluarix; Influsplit SSW; Alpharix]; granted on 8/31/2005 to Sachsische Serumwerke AG for marketing by GlaxoSmithKline for prevention of influenza.

Insulin-like Growth Factor-1, rDNA/Tercica [Insulin-like Growth Factor-1, recombinant - Increlex; IGF-1] granted on 8/31/2005 to Tercica, Inc. (partnered with Genentech) for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone

Calcitonin, rDNA [Calcitonin (salmon) - Fortical; calcitonin, recombinant] granted on 8/15/2005 to Unigene, Inc. (marketed by Upsher-Smith Labs.) for the treatment of postmenopausal osteoporosis

Insulin detemir, rDNA - [Insulin detemir, recombinant - Levemir] granted on 6/17/2005 to Novo Nordisk Inc. for the treatment of diabetes mellitus (type 1 and type 2; [a long-acting recombinant insulin analog]

dTpa booster/Sanofi [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed - Adacel; dTpa; Tdap] granted on 6/10/2005 to Aventis Pasteur Ltd. for use as a tetanus, diptheria and pertussis (whooping cough) booster vaccine for those ages 11-64

Arylsulfatase B, rDNA [N-acetylgalactosamine 4-sulfatase - Naglazyme; Aryplase; galsulfase; chondroitinase; rhASB (recombinant)] - granted on 5/31/2005 to BioMarin Pharmaceutical Inc. for treatment of mucopolysaccharidosis VI (MPS VI).

dTpa booster/GSK [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed - Boostrix; dTpa; Tdap] - granted on 5/3/2005 to GlaxoSmithKline Biologicals S.A. for use as a tetanus, diptheria and pertussis (whooping cough) booster vaccine for those ages 10-18

Tetanus Toxoid/Chiron [Tetanus Toxoid Concentrate (For Further Manufacturing Use]; granted on 5/3/2005 to Chiron Behring GmbH & Co. (Chiron Corp.; merging into Novartis AG) for use as a component of Boostrix combination vaccine (see above entry)

Vaccinia Immune Globulin, i.v./Cangene [VIG; VIVIG] - granted on 5/3/2005 to Cangene Corp. for treatment of rare complications of smallpox vaccination (systemic, severe skin or other serious infections due to the live vaccinia virus in current smallpox vaccines)

Hyaluronidase, rDNA [Cumulase; Enhanze SC; Chemophase; rHuPH20; PH-20 hyaluronidase, recombinant human] - device approval of Cumulase on 4/19/2005; granted to Halozyme Therapeutics, Inc. for use in in vitro fertilization (IVF) procedures (preparation of oocytes prior to in vitro fertilization)

Vaccinia Immune Globulin, i.v./DVC [VIG; VIGIV] - granted on 2/18/2005 to DynPort Vaccine Co. LLC for treatment of rare complications of smallpox vaccination (systemic, severe skin or other serious infections due to the live vaccinia virus in current smallpox vaccines)

Thrombin, conc. [Thrombin (Human) (For Further Manufacturing Use)] - granted on 2/18/2005 to Baxter Healthcare Corp. for further manufacture of FloSeal Matrix Hemostatic Sealant, used to control bleeding

Meningococcal Conjugates Vaccine [Menactra; Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; MCV-4] - granted on 1/14/2005 to Sanofi Pasteur Inc. for protection against meningococcal disease in adolescents and adults aged 11-55 years

2004:

VEGF apatamer, PEG - [Pegaptanib sodium - Macugen; vascular endothelial growth factor/vascular permeability factor (VEGF) aptamer, synthetic oligonucleotide, PEGylated)] granted on 12/17/2004 to Eyetech Pharmaceuticals, Inc. for treatment of neovascular (wet) age-related macular degeneration [synthetic 28-mer oligonucleotide, mimics a VEGF antibody; not a biopharmaceutical].

Keratinocyte growth factor, rDNA* [Palifermin - Kepivance; des1-23 KGF; 24-163 fibroblast growth factor 7 (human)] granted on 12/15/2004 to Amgen Inc. for treatment of severe oral mucositis (mouth sores) in patients with hematologic cancers undergoing high-dose chemotherapy, followed by a bone marrow transplant.

Integrin Mab, rDNA [Tysabri - natalizumab; Antegren; integrin alpha(4) humanized monoclonal antibody] granted on 11/24/2004 to Biogen Idec for treatment of multiple sclerosis [formerly Antegren (trade name), now Tysabri; changed at FDA request].

Hyaluronidase, bovine/Amphastar - [Hyaluronidase, bovine - Amphadase] granted on 10/24/2004 to Amphastar Pharmaceuticals, Inc. for use as a "spreading agent," e.g., as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

Enfuvirtide, synthetic [T-20; Fuzeon; pentafuside; DP-178] full approval (upgraded from accelerated approval granted 3/2003) granted on 10/15/2004 to Hoffmann-La Roche Inc. for the treatment of HIV-1 infection in in combination with other antiretroviral agents in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy [synthetic peptide, not a biopharmaceutical].

CD15 Mab-Tc 99m radioconj. [Technetium (99m Tc) fanolesomab; Neutrospec; Leutech; TC99M-labeled CD15 monoclonal antibody] - granted on 7/2/2004 to Palatin Technologies, Inc. for diagnostic imaging of appendicitis (scintigraphic imaging of patients with equivocal signs of appendicitis who are five years of age or older.)

Luteinizing hormone, rDNA [Lutropin alfa - Luveris; human luteinizing hormone, recombinant] granted to Serono, Inc. on 5/24/204 for infertility treatment [stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency in combination with FSH (Gonal-f)].

Immune Globulin (IGIV)/Octapharma [Octagam; Immune Globulin Intravenous (Human)] - granted on 5/21/2004 to Octapharma AG for treatment of primary immune deficiency.

Hyaluronidase, ovine [Vitrase; hyaluronate 4-glycanohydrolase] granted on 5/4/2004 to ISTA Pharmaceuticals Inc. for use as a spreading agent to facilitate the dispersion and absorption of drugs, particularly local anesthetics, during ophthalmic surgery; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents

Insulin glulisine, rDNA [Apidra; [LysB3, GluB29] insulin; insulin (human), 3B-l-lysine, 29B-l-glutamic acid-, recombinant] - granted on 4/16/2004 to Aventis Pharma for use as a rapid-acting insulin for treatment of diabetes.

VEGF Mab, rDNA [Avastin; bevacizumab; vascular endothelial growth factor monoclonal antibody, recombinant] - granted on 2/26/2004 to Genentech, Inc. for use in combination with 5-fluorouracil for treatment of metastatic cancer of the colon or rectum.

EGF receptor Mab, rDNA [Cetuximab - Erbitux; IMC-C225; epidermal growth factor receptor monoclonal antibody, recombinant] - granted on 2/12/2004 to ImClone Systems Inc. (for marketing by Bristol-Myers Squibb Co.) for use in combination with irinotecan in the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy, and for monotherapy treatment of patients with EGFR-expressing metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy.

Rho(D) Immune Globulin/ZLB [Rho(D) Immune Globulin Intravenous (Human) - Rhophylac] - granted on 2/12/2004 to ZLB Bioplasma AG for antepartum and postpartum prevention of Rho(D) immunization in Rho(D)-negative women.

Hyaluronic acid/Anika [ORTHOVISC High Molecular Weight Hyaluronan] - granted on 2/5/2004 to Anika Therapeutics, Inc. for U.S. marketing by Ortho Biotech Products, L.P. (Johnson & Johnson) for the treatment of pain associated with osteoarthritis of the knee. [Derived from rooster combs; considered a borderline biopharmaceutical product]

2003:

Immune Globulin Intravenous (Human) [Flebogamma] - granted on 12/18/2003 to Instituto Grifols (Probitas Pharma) for treatment of primary immune deficiency.

Hyaluronic acid/Medicis [Restylane] - granted on 12/12/2003 to Medicis Pharmaceutical Corp. for correction of moderate to severe facial wrinkles and folds, e.g., nasolabial folds (lines/folds near the nose and mouth). [bacterial fermentation-derived; considered a mainstream biopharmaceutical product]

CD11a Mab, rDNA [Efalizumab - Raptiva; CD11a monoclonal antibody, recombinant] - granted on 10/27/2003 to Genentech, Inc. and Xoma Ltd. for the treatment of moderate-to-severe psoriasis in adults who are candidates for systemic or phototherapy.

Botulism Immune Globulin Intravenous (Human) [BabyBIG] - granted on 10/23/2003 to the California Department of Health Services for treatment of infant botulism caused by type A or type B Clostridium botulinum.

Somatropin, rDNA/Serono [Somatropin (rDNA origin) - Serostim; human growth hormone, recombinant] - full approval granted on 8/29/2003 to Serono Inc. for the treatment of HIV patients with wasting or cachexia [upgraded from accelerated approval granted in 1996]

Factor VIII, rDNA, PFM [Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method - Advate; Factor VIII, recombinant; rAHF-PFM] - granted on 7/25/2003 to Baxter Hyland Immuno for treatment of hemophilia A.

TNF Receptor-IgG Fc, rDNA [Etanercept - Enbrel; tumor necrosis factor receptor2-immune globlulin G1 Fc fusion protein, recombinant] - supplemental BLA granted on 7/24/2003 to Amgen Inc. for treatment of active ankylosing spondylitis.

Antitrypsin, alpha-1/Aventis [Alpha-1-Proteinase Inhibitor (Human) - Zemaira] - granted on 7/8/2003 to Aventis Behring LLC for chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor deficiency and evidence of emphysema.

CD20 Mab, rDNA--I 131 radioconj. [Iodine I 131 tositumomab - Bexxar; CD20 monoclonal antibody--Iodine I 131 radioimmune conjugate] - granted on 6/27/2003 to Corixa Corp g . (formerly Coulter Pharmaceutical) with marketing by GlaxoSmithKline (GSK) for the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma (NHL), with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy.

Immunoglobulin E Mab, rDNA [Omalizumab - Xolair; rhuMab-E25; immunoglobulin E25 monoclonal antibody, recombinant; IgE Mab, rDNA] - granted on 6/20/2003 to Genentech, Inc. (with manufacture by Tanox, Inc. and co-marketing by Novartis Pharmaceutical Corp.) for treatment of moderate-to-severe allergic asthma.

Hirudin, desulfato- rDNA/Aventis [Iprivask; Desirudin; Revasc; desulfatohirudin; hirudin, desulfato- recombinant] - granted on 4/3/2003 to Aventis Pharma for approved for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery.

Influenza Vaccine, live rDNA, frozen [FluMist] - granted on 6/17/2003 to MedImmune Vaccines, Inc. (subsidiary of MedImmune, Inc.) for influenza prophylaxis in healthy persons from 5-50 year of age.

Iduronidase, rDNA [laronidase; Aldurazyme; alpha-L-iduronidase] - granted on 4/30/2003 to Biomarin Pharmaceutical Inc. (and Genyzme Corp.) for treatment of Mucopolysaccharidosis I (MPS I)

Galactosidase, beta rDNA [Agalsidase beta - Fabrazyme; alpha-galactosidase A] - granted on 4/24/2003 to Genzyme Corp. for treatment of Fabry disease

Somatropin antagonist, PEG-, rDNA [Pegvisomant - Somavert; somatropin antagonist, pegylated, recombinant] - granted on 3/25/2003 to Pharmacia Corp. for treatment of acromegaly

Enfuvirtide, synthetic [T-20; Fuzeon; pentafuside; DP-178] - granted on 3/15/2003 to Hoffmann-La Roche Inc. for treatment of HIV-infection [synthetic; not a biopharmaceutical]

LFA-3/IgG1, rDNA [Alefacept; Amevive; leukocyte function-associated antigen-3/immune globulin G (IgG) fusion protein, recombinant] - granted on 1/30/2003 to Biogen Corp. for treatment of moderate-to-severe chronic plaque psoriasis

Antitrypsin, alpha-1/Baxter [alpha-1 Proteinase Inhibitor (Human); Aralast; alpha-1 antitrypsin; AAT; A1P1] - granted on 1/9/2003 to Alpha Therapeutic Corp. (for marketing by Baxter) for enzyme replacement therapy in patients with heredity emphysema (AAT deficiency)

2002:

TNF Mab, rDNA, human [Adalimumab; Humira; D2E7; tumor necrosis factor-alpha human monoclonal antibody] - granted on 12/30/2002 to Abbott Laboratories for treatment of rheumatoid arthritis

DTaP & Hepatitis B & Polio Vaccine [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix; Infanrix + Engerix-B + IPOL] - a combination vaccine; approval granted on 12/13/2002 to GlaxoSmithKline Inc. for prevention of diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio; Poliovirus vaccine (mixture of three inactivated strains) is the only component not previously approved.

Parathyroid hormone (1-34), rDNA [teriparatide (rDNA origin); Forteo; LY333334; parathyroid hormone (1-34), recombinant] - granted on 11/26/2002 to Eli Lilly & Co. for treatment of osteoporosis

Interferon alfa-2a, rDNA, PEG- [Peginterferon alfa-2a; Pegasys; interferon alpha-2a, recombinant, pegylated] - granted on 10/16/2002 to Hoffmann-La Roche Inc. for first-line treatment of chronic hepatitis C

Urate oxidase, rDNA [uric acid oxidase, recombinant; rasburicase; re-Uox; Elitek; Fasturtec] - granted on 7/16/2002 to Sanofi-Synthelabo for control of plasma uric acid levels (hyperuricaemia) in pediatric patients receiving cancer chemotherapy resulting in tumor lysis and elevation of uric acid

Bone morphogenic protein-2, rDNA [bone morphogenetic protein-2, recombinant; BMP-2; INFUSE Bone Graft] - PMA granted on 7/2/2002 to Medtronic Sofamor Danek using recombinant bmp-2 (from Genetics Institue/Wyeth) as part of the INFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device for treatment of certain types of spinal degenerative disc disease (lumbar spinal fusion)

DTaP Vaccine/Aventis Canada Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) [DAPTACEL] - BLA granted on 5/14/2002 to Aventis Pasteur, Ltd. for the first 4 doses of the diphtheria and tetanus toxoids and pertussis vaccination series administered to infants and children aged 6 weeks up to 7 years

Botulinum Toxin Type A Purified Neurotoxin Complex [BOTOX COSMETIC] - supplemental BLA granted on 4/12/2002 to Allergan, Inc. for temporary improvement in the appearance of moderate to severe glabellar lines ["frown lines"] associated with corrugator and/or procerus muscle activity in adult patients < 65 years of age

Secretin, synthetic [SecreFlo; porcine secretin] - not a biopharmaceutical product (synthetic); granted on 4/5/2002 to Repligen Corp. for diagnosis of gastrinoma (tumors that secrete gastrin) and pancreatic disorders

Interferon beta-1a, rDNA/Serono [Rebif] - granted on 3/7/2002 to Serono, Inc. for treatment of relapsing forms of multiple sclerosis

CD20 Mab/Y-90 radioconj. [Ibritumomab Tiuxetan; Zevalin; a CD20 monoclonal antibody-chelating group conjugate] - granted on 2/29/2002 to IDEC Pharmaceuticals Corp. for treatment of B-cell non-Hodgkin's lymphoma; regimen includes Rituximab, Indium-111 Ibritumomab Tiuxetan, and Yttrium-90 Ibritumomab Tiuxetan

G-CSF, rDNA, PEG- [Pegfilgrastim; Neulasta; pegylated granulocyte-colony stimulating factor] - granted on 1/31/2002 to Amgen, Inc. for treatment of febrile neutropenia in patients receiving chemotherapy for non-myeloid malignancies

Further Information:

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Products database; Companies database - partial entries online

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BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets U.S. Approvals, 2002-present

BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets
U.S. Approvals, 2002-present