New/original, full FDA approvals (almost all BLAs or NDAs) for biopharmaceutical products, unless otherwise noted.  See also 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.

[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 increasingly being 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.

1. 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
2. Glucosidase, rDNA/Lumizyme: [Alglucosidase alfa - Lumizyme; alpha glucosidase; glucosidase alpha; rhGAA]] granted on 5/25/2010 to Genzyme Corp. for treatment of Pompe disease
3. 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
4. Pancreatic Enzymes/J&J: [Pancreaze; Pancreatic Enzyme Product] NDA granted on 4/12/2010 to Johnson & Johnson (J&J) for treatment of pancreatic insufficiency
5. 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.
6. 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
7. 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
8. 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
9. 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
10. Collagenase [clostridial collagenase for injection - Xiaflex] granted on 2/3/2010 to Auxilium Pharmaceuticals Inc. for the treatment of treatment of Dupuytren's disease
11. 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
12. 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)

1. vWF/Factor VIII Complex [Wilate] granted on 12/4/2009 to Octapharma USA, Inc. for the treatment of von Willebrand disease (VWD)
2. 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
3. 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.
4. 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)].
5. 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
6. 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
7. 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
8. 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)
9. 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
10. 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
11. 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
12. 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
13. 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
14. 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
15. 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
16. 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].
17. 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)
18. 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].
19. 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.
20. 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
21. 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
22. 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
23. 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)]:

1. 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)
2. 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].
3. 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)
4. 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].
5. 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].
6. 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
7. 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
8. 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
9. 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].
10. 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).
11. 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].
12. 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
13. Thrombin, rDNA [Recothrom; Thrombin, recombinant; rhThrombin] - granted on 1/17/08 to ZymoGenetics, Inc. to help halt bleeding from small blood vessels after surgery