Biopharmaceuticals produced from tissues & organs (status 2010)

Biopharmaceuticals produced from tissues & organs (status 2010)

Further information on biopharmaceutical products present in the US and European markets can be found at: www.biopharma.com.

Trade name
Generic name
Target
Protein class
Therapeutic area
Company
First EMA approval
First FDA approval
Source
Notes
Method M®/Hemophil M® Antihemophilic factor Factor VIII Blood factor Hemophilia A Baxter Hyland Immuno 1966 / Human plasma
Konyne 80® Antihemophilic factor Factor IX Blood factor Hemophilia B Bayer/Talacris Biotherapeutics 1968 / Human plasma
Proplex-T® Antihemophilic factor Factor IX Blood factor Hemophilia B Baxter Hyland Immuno 1970 / Human plasma
Alphanate® Antihemophilic factor Factor VIII Blood factor Hemophilia A/Von Willebrand disease Grifols Biological 1971 / Human plasma
Koate-DVI® Antihemophilic factor Factor VIII Blood factor Hemophilia A Talecris Biotherapeutics 1974 / Human plasma
Mononine® Antihemophilic factor Factor IX Blood factor Hemophilia B CSL Bioplasma 1984 2004 Human plasma
Humate-P® Antihemophilic factor Factor VIII Blood factor Hemophilia A/Von Willebrand disease CSL Bioplasma 1986 / Human plasma
Thrombin-JMI® Bovine Thrombin Thrombin Blood factor Hemostasis GenTrac 1986 / Bovine plasma
Prolastin® a1-antitrypsin a1-proteinase inhibitor Proteinase inhibitor Congenital a1-proteinase inhibitor
deficiency
Organs 1987 / Human plasma
Adagen® Adenosine deaminase ADA Enzyme ADA deficiency Enon 1990 / Calf intestine
Alphanine SD® Antihemophilic factor Factor IX Blood factor Hemophilia B Grifols Biological 1990 / Human plasma
Profilnine SD® Antihemophilic factor Factor IX Blood factor Hemophilia B Grifols Biological 1990 / Human plasma
Thrombate III® Anthithrombin-III AT-III Glycoprotein Congenital AT-III deficiency Bayer/Talacris Biotherapeutics 1991 1992 Bone marrow
Bebulin VH® Antihemophilic factor Factor IX Blood factor Hemophilia B Baxter 1992 / Human plasma FDA approval withdrawn
Trasylol® Aprotinin Protease Proteinase inhibitor Cardiopulmonary bypass surgery Bayer 1993 / Bovine lung tissue
Monoclate-P® Antihemophilic factor Factor VIII Blood factor Hemophilia A CSL Bioplasma 1996 / Human plasma
Wydase® Hyaluronidase Hyaluronic acid Enzyme Eye surgery Wyeth 2001 / Bovine testes FDA approval withdrawn
Aralast® a1-antitrypsin a1-proteinase inhibitor Proteinase inhibitor Congenital a1-proteinase inhibitordeficiency Alpha Therapeutic/Baxter 2002 / Human plasma
Zemaira® a1-antitrypsin a1-proteinase inhibitor Proteinase inhibitor Congenital a1-proteinase inhibitordeficiency CSL Bioplasma 2003 / Human plasma
Amphadase® (biosimilar) Hyaluronidase Hyaluronic acid Enzyme Eye surgery Amphastar Pharmaceuticals 2004 / Bovine testes
Vitrase® Hyaluronidase Hyaluronic acid Enzyme Eye surgery ISTA Pharmaceuticals 2004 / Ovine tissue
Hydase® Hyaluronidase Hyaluronic acid Enzyme Hypodermoclysis PrimaPharm 2005 / Bovine testes
Cinryz® C1 Esterase C1-Inhibitor Esterase inhibitor Hereditary angioedema Lev Pharmaceuticals/StichtingSanquin Bloedvoorziening 2008 1998 Human plasma
Berinert P® C1 Esterase C1-Inhibitor Esterase inhibitor Hereditary angioedema CSL Behring 2009 / Human plasma
Nonafact® Antihemophilic factor Factor IX Blood factor Hemophilia B Stichting Sanquin Bloedvoorziening / 2001 Human plasma
Respira® a1-antitrypsin a1-proteinase inhibitor Proteinase inhibitor Congenital a1-proteinase inhibitor
deficiency
Kamada Pending / Human plasma

 

Abbreviations

ADA
AT-III
BAFF
BHK
BMP
C-127
CA-125
CD
CEA
CHO
CLL
CTAA
CTLA-4
E.coli
EGF
Adenosine deaminase
Antithrombin-III
B-cell activating factor
Baby hamster kidney cells
Bone morphogenetic protein
Murine mammary tumor derived cell line
Cancer antigen 125
Cluster of differentiation
Carcinoembryonic antigen
Chinese Hamster Ovary
Chronic Lymphocytic Leukemia
Colon tumor-associated antigen
Cytotoxic T-Lymphocyte Antigen 4
Escherichia coli (bacterium)
Epidermal growth factor
EMA
EpCAM
EPO
FDA
FSH
GAG
GPIIb/IIa receptor
HCG
HEK 293
HER2 Receptor
HGH
HT-1080
IgE
IGFBP3
IL-1 Receptor
European Medicine Agency
Epithelial cell adhesion molecule
Erythropoeietin
Food and Drug Administration
Follicle stimulating hormone
Glycosaminoglycans
Glycoprotein IIb/IIa receptor
Human chorionic gonadotrophin
Human embryonic kidney cell line
Human epidermal growth factor receptor 2
Human Growth Hormone
Human fibrosarcoma cell line
Immunoglobulin E
Insulin-like growth factor binding protein 3
Interleukin-1 Receptor
IL-X
MAB
MPS I
MRC-5
NS0
OP-1
PSMA
r-tPA
RSV
Sp2/0
TAG-72
TNF
WI-38
Interleukin-X
Monoclonal Antibody
Mucopolysaccharidose I
Medical Research Council 5 human fetal cells
Mouse myeloma cell line (lymphoblast)
Osteogenic protein 1
Prostate Specific Membrane Antigen
Recombinant tissue plasminogen activator
Respiratory syncytial virus
Mouse myeloma cell line
Tumor-associated glycoprotein 72
Tumor necrosis factor
Wistar Institute 38 human fetal lung tissue

 

Sources/references

BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets
9th annual edition Web database by Ronald A. Rader Biotechnological Information Institute
Nature biotechnology (several years, several authors)
Bioprocess International: 30 years of US-approved cell culture products 2009
Recombinant Protein Therapeutics from CHO-cell — 20 years and counting CHO consortium SBE Special edition
Biopharmaceutical Proteins Opportunities and Challenges John R. Birch and Yemi Onakunle From: Methods in Molecular Biology, vol. 308: Therapeutic Proteins: Methods and Protocols
Edited by: C. M. Smales and D. C. James © Humana Press Inc., Totowa, NJ 2005
The Pink Sheet (several years)

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