Biopharmaceuticals produced with animal cell technology (status 2012)

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
Cell line
Notes
Abbokinase® Urokinase Serine protease Enzyme Pulmonary embolism ImaRx 1978 Primary Human Neonatal Kidney cells
Activase Alteplase tPA Enzyme Acute myocardial infection Genentech 2002 1987 CHO
Epogen®/Procrit® Epoeietin-a EPO Cytokine/receptor antagonist/growth factor Anaemia Genentech 1989 CHO
Recombinate®/
Bioclate®
Antihemophilic factor Factor VIII Blood factor Hemophilia Baxter Healthcare 1992 1992 CHO
Pulmozyme Dornase-a Deoxyribonuclease Enzyme Cystic fibrosis Genentech 1994 1993 CHO
ReoPro® Abciximab GPIIb/IIa receptor Chimeric MAB Cardiovascular disease Eli Lilly 1995 1994 Sp2/0
ProstaScint® Capromab Pendetide PSMA Murine MAB Detection of prostate cancer EUSA Pharma 1996 Hybridoma
Serostim LQ® Somatropin hGH Hormone AIDS cachexia-related indications Merck Serono 1996 C-127
Verluma® Nofetumomab Merpentan CD20 Murine MAB Detection of small cell lung cancer NeoRX 1996 Hybridoma Discontinued
Simulect® Basiliximab IL-2Ra Murine MAB Transplant rejection Novartis/Cerimon Pharmaceuticals 1998 1998 NS0
Rebif® Interferon ß-1a
glycoprotein
Interferon ß-1a Cytokine/receptor antagonist/growth factor Multiple sclerosis Serono 1998 2002 CHO
HumaSPECT® Votumumab CTAA16.88 (or CTA#1)
cytokeratin tumor-associated
complex of antigens
Humanized MAB Radiodiagnosis of colorectal
cancer
Bioreactor Technology 1998 A human lympho-blastoid cell line
transformed with Epstein-Barr virus (EBV)
Zenapax® Daclizumab IL-2Ra Murine MAB Transplant rejection Hoffmann-La Roche 1999 1997 Sp2/0
CEA-Scan® Arcitumomab CEA Murine MAB Detection of colorectal carcinoma Immunomedics 1999 1998 Hybridoma Discontinued
Remicade® Infliximab TNF Chimeric MAB Crohn’s disease/
rheumatoid arthritis
Centocor / J&J 1999 1998 Sp2/0
Synagis® Palivizumab RSV Chimeric MAB RSV disease AstraZeneca/
MedImmune
1999 1998 NS0
Eprex® Epoeietin-a EPO Cytokine/receptor antagonist/growth factor Anaemia Ortho Biotech / J&J 1999 1999 CHO
Mylotarg® Gemtuzumab
Ozogamicin
CD33 Receptor with
Cytotoxin
Murine MAB Acute myeloid leukemia Wyeth 2000 NS0
Kogenate®/Helixate® Octocog a Factor VIII Blood factor Hemophilia A Bayer 2000 1993 BHK
Herceptin® Trastuzumab HER2 Receptor Chimeric MAB Breast cancer Genentech 2000 1998 CHO
Thyrogen® Thyrotropin a TSH Hormone Thyroid cancer Genzyme 2000 1998 CHO
Ovidrel® Choriogonadotropin-a HCG Hormone Infertility Serono 2001 2000 CHO
TNKase® Tenecteplase Modified Human TPA Enzyme Thrombolysis Genentech 2001 2000 CHO
Aranesp® Darbepoetin-a EPO Cytokine/receptor antagonist/growth factor Anaemia Amgen 2001 2001 CHO
Fabrazyme® Agalsidase-ß Human a-galactosidase Enzyme Fabry disease Genzyme 2001 2003 CHO
Replagal® Agalsidase-a Human a-galactosidase Enzyme Fabry disease Shire 2001 Human HT-1080 cell line
Activase® Alteplase Human r-tPA Enzyme Acute myocardial infarction Genentech 2002 1996 CHO
Campath®/MabCampath® Alemtuzumab CD52 Humanized MAB CLL Genzyme 2002 2001 CHO
OP-1 Implant® Eptotermin-a BMP-7 Cytokine/receptor antagonist/growth factor Alternative to autograft Stryker Biotech 2002 2001 CHO
Opgenra® Eptotermin a OP-1 Osteogenic protein Alternative to autograft Stryker Biotech 2002 2001 CHO
Xigris® Drotrecogin a(activated) Human activated Protein C Blood factor Sepsis Eli Lilly 2002 2001 HEK 293
INFUSE® bone graph Dibotermin-a BMP-2 Cytokine/receptor antagonist/growth factor Tibial shaft fractures Wyeth 2002 2002 CHO
Dynepo® Epoetin-delta EPO Hormone Anemia associated with CRF Shire/Sanofi Aventis 2002 Human HT-1080 cell line
Aldurazyme® Iduronidase a-L-Iduronidase Enzyme MPS I Genzyme/BioMarin 2003 2003 CHO
Amevive® Alefacept Leukocyte antigen-3/lgG Fusion protein Chronic plaque psoriasis Astellas Pharma/
Biogen Idec
2003 CHO
Bexxar® Tositumomab CD20 with Iodine -131 Murine MAB Non-Hodgkin’s lymphoma GSK 2003 Hybridoma
Zorbtive® Somatropin hGH Hormone Short bowel syndrome Merck Serono 2003 Murine tumor cell line C-127
Raptiva® Efalizumab CD11a Humanized MAB Psoriasis Genentech/Xoma 2004 2003 CHO FDA & EMA
approval withdrawn
Erbitux® Cetuximab EGF Receptor Chimeric MAB Squamous cell carcinoma/colorectal cancer Eli Lilly 2004 2004 Hybridoma
NeutroSpec® Fanolesomab CD15 Murine MAB Scintigraphic imaging for
appendicitis
Palatin Technologies 2004 Hybridoma FDA & EMA
approval withdrawn
Xolair® Omalizumab lgE Humanized MAB Asthma Genentech/
Novartis/
Tanox
2005 2003 CHO
Avastin® Bevacizumab Vascular endothelial growth factor Humanized MAB Colorectal cancer Genentech/
Hoffmann-La Roche
2005 2004 CHO
Proxinium® Catumaxomab EpCAM Humanized MAB Head and neck cancer Viventia Biotech 2005 2005 CHO
Hylenex® Hyaluronidase PH-20 Glycoprotein IVF Haloyme Therapeutics 2005 CHO
iPlex® Mecasermin rinfibate IGFBO-3 Cytokine/receptor antagonist/growth factor IGF-1 deficiency Insmed 2005 E.coli/CHO
Myozyme®/Lumizyme® Alglucosidase a a-glucosidase Enzyme Pompe disease Genzyme 2006 2006 CHO
Atryn® Antithrombin-III AT-III Glycoprotein Congenital AT-III deficiency Genzyme 2006 2008 Transgenic goat milk
LeukoScan® Sulesomab Human granulocytes Murine MAB Radiodiagnosis of osteomyelitis Immunomedics/
Eli Lilly
2006 NS0
Orencia® Abatacept CTLA4 Receptor Chimeric protein Rheumatoid arthritis Bristol-Myers Squibb 2007 2005 CHO
Elaprase® Idursulfase L-iduronate 2-sulfate Enzyme Hunter syndrome (MPS II) Shire 2007 2006 Human HT-1080 cell line
Vectibix® Panitumumab EGF Receptor Humanized MAB Colorectal cancer Amgen 2007 2006 CHO
Mircera® (pegylated
version of NeoRecormon)
Epoeietin-a EPO Cytokine/receptor antagonist/growth factor Anaemia Hoffmann-La Roche 2007 2007 CHO
Soliris® Eculizumab C5 Humanized MAB Paroxysmal nocturnal
hemoglobinuria
Alexion Pharmaceuticals 2007 2007 NS0
Abseamed® Epoeietin-a Red blood cell progenitor Hormone Anaemia Medice Arzneimittel Putter 2007 CHO
Benecrit® (biosimilar) Epoeietin-a EPO Cytokine/receptor antagonist/growth factor Anaemia Sandoz/Novartis 2007 CHO
Hexal® (biosimilar) Epoeietin-a EPO Cytokine/receptor antagonist/growth factor Anaemia Hexal Biotech/Novartis 2007 CHO
Stada® (biosimilar) Epoeietin-a EPO Cytokine/receptor antagonist/growth factor Anaemia Stada Arzneimittel AG 2007 CHO
Recothrom® rhThrombin Thrombin Blood factor Hemostasis Zymogenetics/Bayer 2008 CHO
Xyntha® (formerly ReFactor®) Moro-octocog a Factor VIII Blood factor Hemophilia A Wyeth 2009 2008 CHO
Ilaris® Canakinumab IL-1ß Receptor Chimeric MAB Cryopyrin-associated periodic
syndromes
Novartis 2009 2009 Sp2/0
Simponi® Golimumab TNF a Chimeric MAB Rheumatoid arthritis Centocor 2009 2009 Sp2/0
Stelara® Usetekinumab IL-12/23 Humanized MAB Psoriasis Centocor/J&J 2009 2009 CHO
Chondrocelect® Chondrocytes Femoral condyle Chondrocytes Cartilage defects TiGenix 2009 Autologous chondrocytes
Removab® Catumaxomab EpCAM/CD3 Chimeric MAB Epithelial cancers Fresenius Biotech 2009 Rat-mouse hybrid hybridoma cell line
Scintimun® Besilesomab CEA Murine MAB Detection of lesions and
metastases
CIS Bio International 2009
Arzerra® Ofatumumab CD20 Humanized MAB CLL GSK 2010 2009 CHO
Vpriv Velaglucurase-a Glucocerebrosidase Enzyme Gaucher disease (type 1) Shire 2010 2010 Human HT-1080 cell line
FSH-CTP® Corifollitropin a FSH Hormone IVF Merck/Organon Teknika 2010 Pending CHO
Actemra® Atlizumab IL-6 receptor Humanized MAB Rheumatoid arthritis Genentech 2009 2010
Prolia® Denosumab EGF Receptor Humanized MAB Postmenopausal osteoporosis Amgen 2010 2010 CHO
Ruconest® / Rhucin® C1 Esterase C1-Inhibitor Esterase inhibitor C1 inhibitor deficiency Pharming 2010 N/A Transgenic rabbit milk
Abthrax® Raxibacumab Macrophage cells Murine MAB Inhalation anthrax Human Genome Sciences Pending NS0
Bosatria® Mepolizumab IL-5 Receptor Humanized MAB Hypereosinophilic syndrome GSK Withdrawn Pending CHO
Medi-524® (NuMax®) Motavizumab RSV Chimeric MAB RSV disease AstraZeneca/
MedImmune
Pending NS0
Nujolix® Belatacept IG1Fc-CTLA4 fragment Fusion protein Transplant rejection Bristol-Myers Squibb 2011 2011 CHO
Lumizyme® Alglucosidase a a-glucosidase Enzyme Pompe disease Genzyme N/A 2010 CHO
Benlysta® Belimumab BLyS
(B-Lymphocyte stimulator protein)
Humanized MAB Systemic lupus erythematosus (SLE) GSK / HGS 2011 2011 NS0
Elonva® Corifollitropin alfa COS (controlled ovarian stimulation) Hormone Infertility Merck 2010 N/A CHO
Xgeva® Denosumab EGF Receptor Humanized MAB SREs (skeletal-related events) Amgen 2011 2010 CHO
Yervoy® Ipilimumab CTLA-4
(cytotoxic
T- lymphocyte antigen-4)
Humanized MAB Melanoma BMS 2011 2011 CHO

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)
Harrison online

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