Antihemophilic Factor (Recombinant) - Bioclate
Status - marketed in U.S., not EU
Organizations involved:
Wyeth – Manuf.; R&D; Tech.; Parent
Genetics Institute, Inc. – R&D; Tech.; Former
Baxter Hyland Immuno – Manuf.; R&D; Tech.
CSL Bioplasma, Inc. – USA mark
CSL Behring AG – Intl. mark.
CSL Ltd.– Parent
Aventis Behring LLC – Former
Aventis Pharma AG – Former
Bayer Schering Corp. – Tech.
Genentech, Inc. – Tech.; Patent dispute
Columbia University – Tech.; Patent dispute
Cross ref.: See the entry (#147) for Recombinate (recombinant Factor VIII from Baxter), which is identical to this product. See the Factor VIII Products entry in the Blood Products, Human section. See also the Factor VIII:vWF, rDNA conc. entry concerning bulk recombinant Factor VIII:C (Factor VIII complexed with Von Willebrand’s Factor) from which Baxter manufactures Recombinate and and this product are manufactured. Note, CSLs Behring also markets a different, baby hamster kidney cell-expressed recombinant Factor VIII product – Antihemophilic Factor (Recombinant), Formulated with Sucrose (Helixate FS).
Description: Bioclate is identical to Recombinate from Baxter Hyland Immuno, which manufactures and repackages the product Bioclate for Aventis Behring, now CSL Behring. See the Recombinate entry for further descriptive information about Bioclate. Bioclate contains recombinant Factor VIII glycoprotein expressed by Chinese hamster ovary (CHO) cells and purified using ion exchange and size exclusion chromatography, and immunoaffinity chromatography using matrix-bound monoclonal antibody. Bioclate contains Albumin (Human) as a stabilizer.
Nomenclature: Factor VIII, rDNA CHO/CSL [BIO]; Bioclate [TR]; Antihemophilic Factor (Recombinant) [FDA]; Antihemophilic Factor [USAN]; Antihemophilic Factor, Human [former USAN]; Antihemophilic Factor USP [USAN]; Factor VIII (rDNA) [BAN]; Blood-coagulation factor VIII, complex [CAS]; 9001-27-8[CAS RN]; Factor VIII, recombinant [SY]
Companies.: Genetics Institute, CBER/FDA est. no. 1163, now merged into Wyeth, CBER/FDA est. no. 0003, developed and manufactures bulk Factor VIII concentrate for further manufacturing use by Baxter Hyland Immuno (Glendale, CA), FDA CBER est. no. 0140. Baxter produces the final purified and packaged product (which it sells under the trade name Recombinate), and provides this same product to Aventis Behring, now CSL Behring, a subsidiariy of CSL Ltd., which markets it under the trade name Bioclate in the U.S. and other major markets.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19921210; first approval, PLA, granted to Baxter for product manufactured by Baxter Healthcare from recombinant Factor VIII manufactured by Genetics Institute, and resold by Centeon LLC (later Aventis Behring, now CSL Behring) under the trade name Bioclate
Indications: [full text of "INDICATIONS AND USAGE” section of product insert/labeling]:
Tech. transfer: See also the Factor VIII:vWF, rDNA conc. entry concerning bulk recombinant Factor VIII:C (Factor VIII:vWF) from which Recombinate from Baxter and this product are manufactured. Centeon LCC, later Aventis Behring, now CSL Behring, licensed marketing rights to recombinant Factor VIII from Baxter Hyland Immuno (and also obtains the product from Baxter). Baxter had licensed rights and manufactures the product from bulk recombinant Factor from Genetics Institute, Inc., now Wyeth.
Market: Average Wholesale Price (AWP) not available (product not in 2007 back to 2004 Red Book). Presumably, the AWP is the same as for Recombinate.
The Center for Medicaid Services (CMS) reimburses outpatient use of recombinant Factor VIII at a rate of $1.01/IU.
The author’s rough guess for 2005 total sales (with no substantive information to work from) is ~$50 million
In June 2003, Aventis Behring, now CSL Behring, launched the Choice Assurance Program. See discussion of this at the end of the Helixate FS entry (#151).
Companies involvement:
Full monograph
152 Factor VIII, rDNA CHO/CSL
[Identical to indications: for Recombinate (#147), except “BIOCLATE” is substituted for “RECOMBINATE]
Nomenclature:
Factor VIII, rDNA CHO/CSL [BIO]
Bioclate [TR]
Antihemophilic Factor (Recombinant) [FDA]
Antihemophilic Factor [USAN]
Antihemophilic Factor, Human [former USAN]
Factor VIII (rDNA) [BAN]
Blood-coagulation factor VIII, complex [CAS]
9001-27-8 [CAS RN]
AHF [SY]
Factor VIII, recombinant [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1992
Date of 1st FDA approval = 19921210
(in format YYYYMMDD)
Biosimilars/biobetters-related U.S. Patents: | 2019, based on 6,475,725 and extension of 6,936,441 |
U.S. Patent Expiration Year: | 2019 |
U.S. Biosimilars Data Exclusivity Expiration: | 2004 |
U.S. Biosimilars Orphan Exclusivity Expiration: | 1999 |
U.S. Biosimilars Launchability Year: | 2019 |
U.S. Biobetters Launchability Year: | 2019 |
Biosimilars/biobetters-related EU Patents: | 2017 (based on EP 0906340 process patent); no EP equivalents of 6475725 or 6,936,441 |
EU Patent Expiration Year: | 2017 |
EU Biosimilars Data Exclusivity Expiration: | |
EU Biosimilars Orphan Exclusivity Expiration: | |
EU Biosimilars Launchability Year: | 2011 (now) |
EU Biobetters Launchability Year: | zzzz |
Index Terms:
antihemophilic factors
biopharmaceutical products
blood products
bovine materials used<!-- bovinesource -->
exempt from CBER lot release requirements
hamster source materials
human materials used<!-- humansource -->
murine (mouse) materials used
recombinant DNA
rodent source materials
albumin, bovine
bovine serum albumin (BSA)
Chinese hamster ovary (CHO) cells
mammalian cell culture
rodent cells <!-- rodentcells -->
Albumin (Human)
calcium chloride
Factor VIII monoclonal antibodies
hamster proteins
histidine
immunoaffinity chromatography
lyophilized (freeze-dried)
murine monoclonal antibody, Factor VIII
murine proteins
polyethylene glycol (PEG)
polysorbate 80 (Tween 80)
sodium chloride
Sterile Water for Injection
tris (tromethamine)
von Willebrand's factor (vWF)
WHO Intl. Standard Factor VIII:C Concentrate
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
EU000 Not yet/Never filed with EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM999 Not Available/Not Marketed in EU
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