Monoclonal Antibodies Approved by the EMA and FDA for Therapeutic Use

Monoclonal Antibodies Approved by the EMA and FDA for Therapeutic Use (status 2017)

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

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)

Amjevita®

Adalimumab

Amgen Europe

TNFα Human IgG1 2017 2016 CHO Arthritis; juvenile rheumatoid arthritis; psoriatic arthritis; rheumatoid colitis; ulcerative Crohn’s disease; psoriasis; spondylitis; ankylosing
Zinplava™ Bezlotoxumab Merck Sharp & Dohme Limited C. difficile
toxin B
Human monoclonal antitoxin antibody
2017
2016 CHO
Enterocolitis; pseudomembranous
Bavencio® Avelumab Merck Sharp & Dohme Limited PD-L1

Human IgG1/κ

Not approved 2017 CHO Metastatic Merkel cell
carcinoma

Dupixent®

Dupilumab

Regeneron Pharmaceuticals Inc

IL-4Rα

Human IgG4 Not approved 2017 CHO Asthma; dermatitis
Imfinzi® Durvalumab Astrazeneca UK PD-L1 Human IgG1/κ Not approved 2017 CHO Metastatic urothelial carcinoma
Ocrevus™ Ocrelizumab Genentech (Roche) CD20 Humanized IgG1κ Not approved 2017 CHO Multiple sclerosis
Siliq Brodalumab Valeant Pharmaceuticals international IL-17RA Human IgG2/κ Not approved 2017 CHO Psoriasis
Cinqair™ Reslizumab Teva Pharmaceuticals Limited IL-5 Human IgG4/κ 2016 2016 NSO Asthma
Lartruvo Olaratumab Eli Lilly PDGFR-α Human IgG1 2016 2016 CHO Sarcoma
Darzalex® Daratumumab Janssen-Cilag CD38 Human IgG1/κ 2016 2015 CHO Multiple myeloma
Empliciti Elotuzumab Bristol-Myers Squibb SLAMF7 Human IgG1 2016 2015 NS0 Multiple myeloma
Portrazza Necitumumab Eli Lilly EGFR Human IgG1 2016 2015 NS0 Carcinoma, non-small-cell lung
Inflectra Infliximab Hospira UK Limited TNFα Chimeric human-murine IgG1 2013 2016 Sp2/0-Ag14 Spondylitis; ankylosing; arthritis; rheumatoid colitis; ulcerative arthritis; psoriatic Crohn’s Disease; psoriasis
Anthim® Obiltoxaximab Elusys Therapeutics INC PA component of B. anthracis toxin Chimeric (mouse/human) IgG1/κ Not approved 2016 NS0 Anthrax infection
Tecentriq® Atezolizumab Genentech (Roche) PD-L1  Human IgG1 Not approved 2016 CHO Metastatic non-small cell lung cancer
Cosentyx™ Secukinumab Novartis Europharm interleukin-17A Human IgG1/κ 2015 2015 CHO Arthritis; psoriatic psoriasis; spondylitis; ankylosing
Nucala Mepolizumab GlaxoSmithKline IL-5 Human IgG1/κ 2015 2015 CHO Asthma
Opdivo Nivolumab Bristol-Myers Squibb Pharma PD-1 Human IgG4 2015 2015 CHO Carcinoma; non-small-cell lung carcinoma; renal cell Hodgkin disease melanoma
Praluent Alirocumab sanofi-aventis groupe PCSK9 Human IgG1 2015 2015 CHO Dyslipidemias
Praxbind® Idarucizumab Boehringer Ingelheim International GmbH dabigatran etexilate Human FaB 2015 2015 CHO Hemorrhage
Repatha® Evolocumab Amgen LDL-C / PCSK9 Human IgG2 2015 2015 CHO Dyslipidemias; hypercholesterolemia
Unituxin Dinutuximab United Therapeutics Europe GD2 Human IgG1/κ 2015 (1) 2015 Sp2/0 Neuroblastoma
Blincyto® Bevacizumab Amgen Europe CD19 BiTEs 2015 2014 CHO Precursor cell lymphoblastic leukemia-lymphoma
Keytruda® Pembrolizumab Merck Sharp & Dohme Limited PD-1 Human IgG4 2015 2014 CHO Melanoma
Cyramza Ramucirumab Eli Lilly VEGF Human IgG1 2014 2014 NS0 Stomach neoplasms
Entyvio® Vedolizumab Takeda Pharma Integrin-α4β7 HumanizedIgG1 2014 2014 CHO Colitis; ulcerative Crohn’s disease
Sylvant® Siltuximab Janssen-Cilag International cCLB8 Chimeric IgG1κ 2014 2014 CHO Giant lymph node hyperplasia
Lemtrada® Alemtuzumab Sanofi CD52 Humanized IgG1 2013 2014 CHO Multiple sclerosis
Kadcyla® Trastuzumab emtansine Roche HER2 Humanized IgG1 as ADC 2013 2013 CHO Breast cancer
Perjeta® Pertuzumab Roche HER2 Humanized IgG1 2013 2012 CHO Breast cancer
Remsima® Infliximab Celltrion Healthcare TNF-alpha Chimeric IgG1 Ab 2013 Not approved CSC-Ps0006 Spondylitis; ankylosing arthritis; rheumatoid colitis; ulcerative Crohn’s disease; arthritis; psoriatic psoriasis
Gazyvaro® Obinutuzumab Roche CD20 Humanized IgG1 Not approved 2013 CHO CLL
Adcetris® Brentuximab Seattle Genetics CD30 (conjugateof Mab and MMAE) Chemeric IgG1 as ADC (antibody drug conjugate) 2012 2011 CHO Hodgkin lymphoma (HL), systemic anaplastic large cell lymphoma (ALCL)
ABthrax® Raxibacumab HGS (Human Genome Sciences Inc.) Bacillus anthracis protective antigen Human IgG1 Not approved 2012 NS0 Prevention and treatment of inhalation anthrax
Benlysta® Belimumab HSG, GSK BLyS Human IgG1 2011 2011 NS0 Systemic lupus erythematosus (SLE)
Vervoy® Ipilimumab BMS CTLA-4 Human IgG1 2011 2011 CHO Melanoma
Xgeva® Denosumab Amgen RANKL Human IgG2 2011 2011 CHO Prevention of SREs in patients with bone metastases from solid tumours
Prolia® Denosumab Amgen RANKL Human IgG2 2010 2010 CHO Osteoporosis
Arzerra® Ofatumumab Genmab and GSK CD20 Human IgG1 2010 2009 NS0 Chronic lymphocytic leukemia
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
RoActemra® Tocilizumab Chugai (Roche) IL-6 receptor Humanized IgG1 2009 2010 CHO 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; tumor necrosis factor receptor associated periodic syndrome (TRAPS); hyperimmunoglobulin D Syndrome (HIDS)/mevalonate kinase deficiency (MKD) and familial mediterranean fever (FMF)
Simponi® Golimumab Centocor Ortho Biotech (Johnson & Johnson) TNFa Human IgG1 2009 2009 Sp2/0 Rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis
Stelara® Ustekinumab Centocor Ortho Biotech (Johnson & Johnson) IL-12 / IL-23 Human IgG1 2009 2009 Sp2/0 Plaque psoriasis
Cimzia® Certolizumab pegol UCB TNFa Humanized IgG Fab fragment 2009 2008 E. coli Chron’s disease; rheumatoid arthritis
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
Soliris® Eculizumab Alexion Pharmaceuticala Complement C5 Humanized IgG2/4 2007 2007 NS0 Paroxysmal nocturnal hemoglobinuria

Lucentis®

Ranibizumab

Genentech (Roche)

VEGF-A Humanized IgG1 Fab fragment 2007 2006 E. coli Neovascular (wet) age-related macular degeneration; macular edema following retinalvein occlusion
Vectibix® Panitumumab Amgen EGFR Human IgG2
2007
2006 CHO
Metastatic colorectal carcinoma

Tysabri®

Natalizumab

Biogen Idec and Elan

VLA-4 Humanized IgG4 2006 2004 Murine myeloma Multiple sclerosis (relapsing); Crohn’s disease
Proxinium® Catumaxomab Viventia (Eleven Biotherapeutics) EpCAM Humanized MAb
2005
2005 CHO
Head and neck cancer

Avastin®

Bevacizumab

Genentech (Roche)

VEGF Humanized IgG1 2005 2004 CHO Metastatic colorectal cancer; non-small cell lung cancer; metastatic breast cancer; hlioblastoma multiforme; metastatic renal cell carcinoma
Xolair® Omalizumab Genentech (Roche) and Novartis IgE Humanized IgG1
2005
2003 CHO
Asthma

Erbitux®

Cetuximab

ImClone (Eli Lilly), Merck Serono and BMS EGFR Chimeric IgG1 2004 2004 Sp2/0 Head and neck cancer; colorectal cancer
Raptiva® Efalizumab Merck Serono, Genentech (Roche) CD11a Humanized IgG1
2004 (2)
2003 (2) CHO
Psoriasis

Zevalin®

Ibritumomab tiuxetan

Biogen Idec

CD20 Murine IgG1 2004 2002 CHO Non-Hodgkin’s lymphoma
NeutroSpec® (Diagnostic) Fanolesomab Palatin CD15 Murine MAb
Not approved
2004 Hybridoma
Imaging of equivocal appendicitis –> non-therapeutic

Humira®

Adalimumab

Abbott

TNFα Human IgG1 2003 2002 CHO Rheumatoid arthritis; juvenile idiopathic arthritis; psoriatic arthritis; ankylosing spondylitis; Crohn’s disease, plaque psoriasis
Bexxar® Tositumomab and iodine 131 tositumomab Corixa and GSK CD20 Murine IgG2a
Not approved
2003 Hybridoma
Non-Hodgkin’s lymphoma

Campath®

Alemtuzumab

Millennium Pharmaceuticals and Genzyme

CD52 Humanized IgG1 2001 2001 CHO B-cell chronic lymphocytic leukemia
Herceptin® Trastuzumab Genentech(Roche) HER-2 Humanized IgG1 2000 1998 CHO
Breast cancer; metastatic gastric or gastroesophageal junction adenocarcinoma

Mylotarg®

Gemtuzumab ozogamicin

Wyeth

CD33 Humanized IgG4 / toxin conjugate Not approved 2000 (3) NS0 Acute myeloic leucemia (AML)
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)
Daclizumab Necitumumab Roche CD25 (a chain of IL2 receptor) Humanized IgG1
1999 (4)
1997 (4) Sp2/0
Reversal of transplantation rejection

Simulect®

Basiliximab

Novartis

CD25 (a chain of IL2 receptor) Chimeric IgG1 1998 1998 NS0 Reversal of transplantation rejection
Rituxan® MabThera® Rituximab Biogen Idec, Genentech (Roche) CD20 Chimeric IgG1
1998
1997 CHO
Non-Hodgkin’s lymphoma; chronic lymphocytic leukemia; rheumatoid arthritis

Humaspect® (Diagnostic)

Votumumab

Organon Teknica

Cytokeratintumor-associated antigen 1998 (5) Not approved Human lympho-blastoid cell line transformed with EBV Detection of carcinoma of thecolon or rectum –> non-therapeutic
LeukoScan® (Diagnostic) Sulesomab Immunomedics NCA90 Murine Fab fragment 1997 Not approved NS0
Diagnostic imaging forosteomyelitis –> non-therapeutic

CEA-scan® (Diagnostic)

Arcitumomab

Immunomedics

Human CEA (carcinoembryonic antigen) Murine Fab fragment 1996 (6) 1996 Hybridoma Detection of colorectal cancer –> non-therapeutic
MyoScint® (Diagnostic) Imiciromab Centocor Human cardiac myosin Murine Fab fragment
Not approved
1996 (7) 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
Verluma® (Diagnostic) Nofetumomab Boehringer Ingelheim, NeoRx Carcinoma-associated antigen Murine Fab fragment
Not approved
1996 Hybridoma
Diagnostic imaging of small-celllung cancer –> non-therapeutic

ReoPro®

Abciximab

Centocor Ortho Biotech (Johnson & Johnson), Elli Lily

GPIIb/IIIa Chimeric IgG1 Fab 1995 (8) 1994 Sp2/0 High risk angioplasty (prevention of blood clots)
OncoScint® Satumomab Cytogen TAG-72 Murine MAb
Not approved
1992 Hybridoma
Detection of colorectal and ovarian cancers –> non-therapeutic

Orthoclone OKT3®

Muromonab-CD3

Centocor Ortho Biotech (Johnson & Johnson)

CD3 Murine IgG2a 1986 (8) 1986 Hybridoma Transplantation rejection

Notes

(1): Unituxin has been withdrawn from use in the European Union.
(2): 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.
(3): Mylotarg® was approved in 2000 by the FDA. It was voluntarily withdrawn from the market in US in 2010.
(4): 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.
(5): Humaspect® was approved in 1998 by the EMA. It was withdrawn from the market in EU in 2003.
(6): CEA-scan was approved in 1996 by the FDA and by the EMA. It was withdrawn from the market in EU in 2005.
(7): Myoscint® has been discontued.
(8): Country-specific approval (prior to EMA Centralized Procedure).

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.
Walsh, Gary: New biopharmaceuticals. BioPharm International 25(6), 34-38
Dübel, Stefan (Ed.: Handbook of Therapeutic Antibodies, Wiley-VCH, 2010.
Company press releases
Prescribing Information documents

Status: 18.05.2017

©2017 ACTIP

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