Animal Cell Technology Industrial Platform  
   last update Januari 2014


 

 
 

 
 
 

Monoclonal Antibodies Approved by the EMA and FDA for Therapeutic Use

The table below shows the mAbs approved by the European Medicines Agency (EMA) and by the
US Food and Drug Administration (FDA) for therapeutic use (completed 27th November 2013)

Trade Name
International Non-proprietary Name (INN)

Company

Target

Type

Year of first EU EMA approval

Year of first FDA approval

Cell Line
Therapeutic indication(s)

Orthoclone OKT3®

Muromonab-DC3

Centocor Ortho Biotech (Johnson & Johnson)

CD3

Murine IgG2a

1986 (1)

1986

Hybridoma
Transplantation rejection

OncoScint®

Satumomab

Cytogen

TAG-72

Murine MAb

Not approved

1992

Hybridoma
Detection of colorectal and ovarian cancers
—>non-therapeutic

ReoPro®

Abciximab

Centocor Ortho Biotech (Johnson & Johnson),
Eli Lilly

GPIIb/IIIa

Chimeric IgG1 Fab

1995 (1)
1994
Sp2/0
High risk angioplasty
(prevention of blood clots)

Verluma®
(Diagnostic)

Nofetumomab

Boehringer Ingelheim, NeoRx

Carcinoma-associated antigen

Murine Fab fragment

Not approved
1996
Hybridoma
Diagnostic imaging of small-cell
lung cancer —>non-therapeutic

MyoScint®
(Diagnostic)

Imiciromab

Centocor

Human cardiac myosin

Murine Fab fragment

Not approved

1996

Murine ascites
Myocardial infarction imaging agent —>non-therapeutic

ProstaScint®
(Diagnostic)

Capromab

Cytogen

Tumor surface antigen PSMA

Murine MAb

Not approved

1996

Hybridoma
Detection of prostate adenocarcinoma
—>
non-therapeutic

CEA-scan®
(Diagnostic)

Arcitumomab

Immunomedics

Human CEA (carcinoembryonic antigen)

Murine Fab fragment

1996 (2)

1996

Hybridoma
Detection of colorectal cancer
—>
non-therapeutic

LeukoScan®
(Diagnostic)

Sulesomab

Immunomedics

NCA90

Murine Fab fragment

1997

Not approved

NS0
Diagnostic imaging for
osteomyelitis —>non-therapeutic

Rituxan®
MabThera®

Rituximab

Biogen Idec, Genentech (Roche)

CD20

Chimeric IgG1

1998

1997

CHO
Non-Hodgkin’s lymphoma
Chronic lymphocytic leukemia
Rheumatoid arthritis

Zenapax®

Daclizumab

Roche

CD25 (a chain of IL2 receptor)

Humanized IgG1

1999 (3)

1997 (3)

Sp2/0
Reversal of transplantation rejection

Simulect®

Basiliximab

Novartis

CD25 (a chain of IL2 receptor)

Chimeric IgG1

1998

1998

NS0
Reversal of transplantation rejection

Remicade®

Infliximab

Centocor Ortho Biotech (Johnson & Johnson)

TNFα

Chimeric IgG1

1999

1998

Sp2/0
Crohn’s disease
Ulcerative colitis
Rheumatoid arthritis
Ankylosing spondylitis
Psoriatic arthrits
Plaque psoriasis

Synagis®

Palivizumab

MedImmune, Abbott

F-protein of RS virus

Humanized IgG1

1999

1998

NS0
Respiratory Syncytial Virus (RSV)

Herceptin®

Trastuzumab

Genentech
(Roche)

HER-2

Humanized IgG1

2000

1998

CHO
Breast cancer
Metastatic gastric or gastroesophageal junction adenocarcinoma

Humaspect®
(Diagnostic)

Votumumab

Organon Teknica

Cytokeratin
tumor-associated antigen

 

1998 (4)

Not approved

Human lympho-blastoid cell line transformed with EBV
Detection of carcinoma of the
colon or rectum
—>non-therapeutic
Mylotarg®
Gemtuzumab ozogamicin

Wyeth

CD33

Humanized IgG4 / toxin conjugate
Not approved

2000 (5)

NS0
Acute myeloic leucemia (AML)

Humira®

Adalimumab

Abbott

TNFα

Human IgG1
2001

2001

CHO
Rheumatoid arthritis
Juvenile idiopathic arthritis
Psoriatic arthritis
Ankylosing spondylitis
Crohn’s disease
Plaque psoriasis

Campath®

Alemtuzumab

Millennium Pharmaceuticals and Genzyme

CD52

Humanized IgG1

2001

2001

CHO
B-cell chronic lymphocytic leukemia

Zevalin®

Ibritumomab tiuxetan

Biogen Idec

CD20

Murine IgG1

2004

2002

CHO
Non-Hodgkin’s lymphoma
Raptiva®

Efalizumab

Merck Serono, Genentech (Roche)

CD11a

Humanized IgG1
2004 (6)
2003 (6)
CHO
Psoriasis
Xolair®

Omalizumab

Genentech (Roche) and Novartis

IgE
Humanized IgG1
2005

2003

CHO
Asthma

Bexxar®

Tositumomab and iodine 131 tositumomab

Corixa and GSK

CD20

Murine IgG2a

Not approved

2003

Hybridoma
Non-Hodgkin’s lymphoma

Avastin®

Bevacizumab

Genentech (Roche)

VEGF

Humanized IgG1

2005

2004

CHO
Metastatic colorectal cancer
Non-small cell lung cancer
Metastatic breast cancer
Glioblastoma multiforme
Metastatic renal cell carcinoma

Erbitux®

Cetuximab

ImClone (Eli Lilly), Merck Serono and BMS

EGFR

Chimeric IgG1

2004

2004

Sp2/0
Head and neck cancer
Colorectal cancer

NeutroSpec®
(Diagnostic)

Fanolesomab

Palatin

CD15

Murine MAb

Not approved

2004

Hybridoma
Imaging of equivocal appendicitis —>non-therapeutic
Tysabri®
Natalizumab
Biogen Idec
and Elan
VLA-4
Humanized IgG4
2006
2004
Murine myeloma
Multiple sclerosis (relapsing)
Crohn’s disease
Proximium®
Catumaxomab
Viventia
EpCAM
Humanized MAb
2005
2005
CHO
Head and neck cancer
Vectibix®
Panitumumab
Amgen
EGFR
Human IgG2
2007
2006
CHO
Metastatic colorectal carcinoma
Lucentis®
Ranibizumab
Genentech (Roche)
VEGF-A
Humanized IgG1 Fab fragment
2007
2006
E. coli
Neovascular (wet) age-related macular degeneration
Macular edema following retinal
vein occlusion
Soliris®
Eculizumab
Alexion Pharmaceuticala
Complement C5
Humanized IgG2/4
2007
2007
NS0
Paroxysmal nocturnal hemoglobinuria
Cimzia®
Certolizumab pegol
UCB
TNFa
Humanized IgG Fab fragment
2009
2008
E. coli
Crohn’s disease
Rheumatoid arthritis
Ilaris®
Canakinumab
Novartis
IL-1ß
Human IgG1
2009
2009
Sp2/0
Cryopyrin-associated periodic syndromes, including familial cold autoinflammatory syndrome and Muckle-Wells syndrome
Removab®
Catumaxomab
Fresenius
EpCAM and CD3
Trifunctional MAb IgG2a / IgG2b
2009
Not approved
Rat-Mouse hybrid hybridoma
Malignant ascites in patients with EpCAM-positive carcinomas
Simponi®
Golimumab
Centocor Ortho Biotech (Johnson & Johnson)
TNFa
Human IgG1
2009
2009
Sp2/0
Rheumatoid arthritis
Psoriatic arthritis
Ankylosing spondylitis
Arzerra®
Ofatumumab
Genmab and GSK
CD20
Human IgG1
2010
2009
NS0
Chronic lymphocytic leukemia
Actemra®
Tocilizumab
Chugai (Roche)
IL-6 receptor
Humanized IgG1
2009
2010
CHO
Rheumatoid arthritis
Stelara®
Ustekinumab
Centocor Ortho Biotech (Johnson & Johnson)

IL-12 / IL-23

Human IgG1
2009
2009
Sp2/0
Plaque psoriasis
Scintimun®
(Diagnostic)
Besilesomab
CIS Bio
NCA-95
Murine IgG1
2010
Not approved
Hybridoma
In vivo diagnosis of inflammation / infection sites via scintigraphic imaging —> non-therapeutic
Prolia®
Denosumab
Amgen
RANKL
Human IgG2
2010
2010
CHO
Osteoporosis
Benlysta®
Belimumab
HSG, GSK
BLyS
Human IgG1
2011
2011
NS0
Systemic lupus erythematosus (SLE)
Adcetris®
Brentuximab
Seattle Genetics
CD30 (conjugate
of Mab and MMAE)
Chimeric IgG1 as ADC (antibody drug conjugate)
2012
2011
CHO
Hodgkin lymphoma (HL),
systemic anaplastic large cell lymphoma (ALCL)
Xgeva®
Denosumab
Amgen
RANKL
Human IgG2
2011
2011
CHO
Prevention of SREs in patients with bone metastases from solid tumours
Vervoy®
Ipilimumab
BMS
CTLA-4
Human IgG1
2011
2011
CHO
Melanoma
Perjeta®
Pertuzumab
Roche
HER2
Humanized IgG1
2013
2012
CHO
Breast cancer
ABthrax®
Raxibacumab
HGS (Human Genome Sciences Inc.)
Bacillus anthracis protective antigen
Human IgG1
Not approved
2012
NS0
Prevention and treatment of inhalation anthrax
Gazyva®
Obinutuzumab
Roche
CD20
Humanized IgG1
Not approved
2013
CHO
CLL
Kadcyla®
Trastuzumab emtansine
Roche
HER2
Humanized IgG1 as ADC
2013
2013
CHO
Breast cancer

 

Notes:
(1): Country-specific approval (prior to EMA Centralized Procedure).
(2): CEA-scan was approved in 1996 by the FDA and by the EMA. It was withdrawn from the market in EU in 2005.
(3): Zenapax® was approved in 1997 by the FDA and in 1999 by the EMA. It was withdrawn from the market for commercial reasons in EU in 2009 and in US in 2009.
(4): Humaspect® was approved in 1998 by the EMA. It was withdrawn from the market in EU in 2003.
(5): Mylotarg® was approved in 2000 by the FDA. It was voluntarily withdrawn from the market in US in 2010.
(6): Raptiva® was approved in 2003 by the FDA and in 2004 by the EMA. It was voluntarily withdrawn from the market in EU in 2009 and in US in 2009.

Sources:
www.pei.de/EN/medicinal-products
www.ema.europa.eu/ema
www.fda.gov/drugs/informationondrugs/approveddrugs
www.antibodysociety.org

Table of approved biopharma products (Nature Biotechnology 28 (2010), 917-924
Leavy, Olive: Therapeutic antibodies: past, present and future. Nature Reviews Immunology 10, 297 (May 2010)
Walsh, Gary: Biopharmaceuticals: Biochemistry and Biotechnology, Wiley-VCH, 2013. ISBN 978-0-470-84327-7
Walsh, Gary: New biopharmaceuticals. BioPharm International 25(6), 34-38
Dübel, Stefan (Hrsg.: Handbook of Therapeutic Antibodies, Wiley-VCH, 2010. ISBN 978-3-527-32902-1
Company press releases
Prescribing Information documents

Status: 23.12.2013

 

     
      © Januari 2014 ACTIP