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You are here: Home / Web Resources / Antibody therapeutics approved or in regulatory review in the EU or US

Antibody therapeutics approved or in regulatory review in the EU or US

The Antibody Society maintains a comprehensive list of approved antibody therapeutics and those in regulatory review in the European Union (EU) or United States (US). In the table below, product candidates undergoing review are listed first, and approved products are listed in reverse chronological order by year of first approval. Products that were granted approvals but subsequently withdrawn from the market are included in the table. Biosimilar products are excluded.

  • European Medicines Agency’s medicine-related data can be downloaded here, and information about medicines under evaluation can be found here.
  • Information about therapeutics approved in the US can be found at Drugs@FDA.
  • Antibody therapeutics that were granted a first approval in regions other than the EU or US are listed at the end of the table.

Click here to download an Excel file of the data.

As of December 21, 2020, 12 antibody therapeutics had been granted first approvals in the US in 2020, and an additional 16 are in regulatory review.

Therapeutic monoclonal antibodies approved or in review in the EU or US.

INN Brand name Target; Format 1st indication approved / reviewed 1st EU approval year 1st US approval year
Amivantamab (Pending) EGFR, cMET; Human bispecific IgG1 NSCLC w/ EGFR exon 20 insertion mutations Review Review
Ublituximab (Pending) CD20; Chimeric IgG1 Chronic lymphocytic leukemia NA Review
Anifrolumab (Pending) IFNAR1; Human IgG1 Systemic lupus erythematosus Review Review
Loncastuximab tesirine (Pending) CD19; Humanized IgG1 ADC Diffuse large B-cell lymphoma NA Review
Balstilimab (Pending) PD-1; Human IgG4 Cervical cancer NA Review
Bimekizumab (Pending) IL-17A,F; Humanized IgG1 Psoriasis Review Review
Tralokinumab (Pending) IL-13; Human IgG4 Atopic dermatitis Review Review
Evinacumab (Pending) Angiopoietin-like 3; Human IgG4 Homozygous familial hypercholesterolemia Review Review
Sutimlimab (Pending) C1s; Humanized IgG4 Cold agglutinin disease NA Review
Aducanumab (Pending) Amyloid beta; Human IgG1 Alzheimer’s disease Review Review
Teplizumab (Pending) CD3; Humanized IgG1 Type 1 diabetes NA Review
Dostarlimab (Pending) PD-1; Humanized IgG4 Endometrial cancer Review Review
Tanezumab (Pending) Nerve growth factor; Humanized IgG2 Osteoarthritis pain Review Review
Inolimomab (Pending) CD25; Mouse IgG1 Host vs. graft disease NA Review
Oportuzumab monatox (Pending) EpCAM; Humanized scFv immunotoxin Bladder cancer NA Review
Narsoplimab (Pending) MASP-2; Human IgG4 Hematopoietic stem cell transplant-associated thrombotic microangiopathies NA Review
Ansuvimab Ebanga Ebola virus; Human IgG1 Ebola infection NA 2020
Margetuximab MARGENZA HER2; Chimeric IgG1 HER2+ breast cancer NA 2020
Naxitamab DANYELZA GD2; Humanized IgG1 High-risk neuroblastoma and refractory osteomedullary disease NA 2020
Atoltivimab, Maftivimab, and Odesivimab-ebgn Inmazeb Ebola virus; mixture of 3 human IgG1 Ebola virus infection NA 2020
Belantamab mafodotin BLENREP BCMA; Humanized IgG1 ADC Multiple myeloma 2020 2020
Tafasitamab Monjuvi CD19; Humanized IgG1 Diffuse large B-cell lymphoma Review 2020
Satralizumab Enspryng IL-6R; Humanized IgG2 Neuromyelitis optica and neuromyelitis optica spectrum disorders Review 2020
Inebilizumab Uplizna CD19; Humanized IgG1 Neuromyelitis optica and neuromyelitis optica spectrum disorders Review  2020
Sacituzumab govitecan Trodelvy TROP-2; Humanized IgG1 ADC Triple-neg. breast cancer NA  2020
Teprotumumab Tepezza IGF-1R; Human IgG1 Thyroid eye disease NA 2020
Isatuximab Sarclisa CD38; Chimeric IgG1 Multiple myeloma 2020 2020
Eptinezumab Vyepti CGRP; Humanized IgG1 Migraine prevention Review 2020
[fam]-trastuzumab deruxtecan Enhertu HER2; Humanized IgG1 ADC HER2+ breast cancer Pos. opin. 2019
Enfortumab vedotin Padcev Nectin-4; Human IgG1 ADC Urothelial cancer NA 2019
Crizanlizumab Adakveo P-selectin; Humanized IgG2 Sickle cell disease 2020 2019
Brolucizumab BEOVU VEGF-A; Humanized scFv Macular degeneration 2020 2019
Polatuzumab vedotin Polivy CD79b; Humanized IgG1 ADC Diffuse large B-cell lymphoma 2020 2019
Risankizumab Skyrizi IL-23p19; Humanized IgG1 Plaque psoriasis 2019 2019
Romosozumab Evenity Sclerostin; Humanized IgG2 Osteoporosis in postmenopausal women at risk of fracture 2019 2019
Caplacizumab Cablivi von Willebrand factor; Humanized Nanobody Acquired thrombotic thrombo- cytopenic
purpura
2018 2019
Ravulizumab Ultomiris C5; Humanized IgG2/4 Paroxysmal nocturnal hemoglobinuria 2019 2018
Emapalumab Gamifant IFNgamma; Human IgG1 Primary hemophagocytic lymphohistiocytosis NA 2018
Cemiplimab Libtayo PD-1; Human IgG4 Cutaneous squamous cell carcinoma 2019 2018
Fremanezumab Ajovy CGRP; Human IgG2 Migraine prevention 2019 2018
Moxetumomab pasudotox Lumoxiti CD22; Murine IgG1 dsFv immunotoxin Hairy cell leukemia Pos. opin. 2018
Galcanezumab Emgality CGRP; Human IgG4 Migraine prevention 2018 2018
Lanadelumab Takhzyro Plasma kallikrein; Human IgG1 Hereditary angioedema attacks 2018 2018
Mogamuizumab Poteligeo CCR4; Humanized IgG1 Cutaneous T cell lymphoma 2018 2018
Erenumab Aimovig CGRP receptor; Human IgG2 Migraine prevention 2018 2018
Tildrakizumab Ilumya IL-23p19; Humanized IgG1 Plaque psoriasis 2018 2018
Ibalizumab Trogarzo CD4; Humanized IgG4 HIV infection 2019 2018
Burosumab Crysvita FGF23; Human IgG1 X-linked hypophosphatemia 2018 2018
Durvalumab IMFINZI PD-L1; Human IgG1 Bladder cancer 2018 2017
Emicizumab Hemlibra Factor IXa, X; Humanized IgG4, bispecific Hemophilia A 2018 2017
Benralizumab Fasenra IL-5Rα; Humanized IgG1 Asthma 2018 2017
Ocrelizumab OCREVUS CD20; Humanized IgG1 Multiple sclerosis 2018 2017
Guselkumab TREMFYA IL-23 P19; Human IgG1 Plaque psoriasis 2017 2017
Inotuzumab
ozogamicin
BESPONSA CD22; Humanized IgG4, ADC Hematological malignancy 2017 2017
Sarilumab Kevzara IL-6R; Human IgG1 Rheumatoid arthritis 2017 2017
Dupilumab Dupixent IL-4Rα; Human IgG4 Atopic dermatitis 2017 2017
Avelumab Bavencio PD-L1; Human IgG1 Merkel cell carcinoma 2017 2017
Brodalumab Siliq, LUMICEF IL-17R; Human IgG2 Plaque psoriasis 2017 2017
Atezolizumab Tecentriq PD-L1; Humanized IgG1 Bladder cancer 2017 2016
Bezlotoxumab Zinplava Clostridium difficile enterotoxin B; Human IgG1 Prevention of Clostridium difficile infection recurrence 2017 2016
Olaratumab Lartruvo PDGRFα; Human IgG1 Soft tissue sarcoma 2016 2016
Reslizumab Cinqaero, Cinqair IL-5; Humanized IgG4 Asthma 2016 2016
Obiltoxaximab Anthim Protective antigen of B. anthracis exotoxin; Chimeric IgG1 Prevention of inhalational anthrax 2020 2016
Ixekizumab Taltz IL-17a; Humanized IgG4 Psoriasis 2016 2016
Daratumumab Darzalex CD38; Human IgG1 Multiple myeloma 2016 2015
Elotuzumab Empliciti SLAMF7; Humanized IgG1 Multiple myeloma 2016 2015
Necitumumab Portrazza EGFR; Human IgG1 Non-small cell lung cancer 2015 2015
Idarucizumab Praxbind Dabigatran;
Humanized Fab
Reversal of dabigatran-induced anticoagulation 2015 2015
Alirocumab Praluent PCSK9; Human IgG1 High cholesterol 2015 2015
Mepolizumab Nucala IL-5; Humanized IgG1 Severe eosinophilic asthma 2015 2015
Evolocumab Repatha PCSK9; Human IgG2 High cholesterol 2015 2015
Dinutuximab Unituxin GD2; Chimeric IgG1 Neuroblastoma 2015 2015
Secukinumab Cosentyx IL-17a; Human IgG1 Psoriasis 2015 2015
Nivolumab Opdivo PD1; Human IgG4 Melanoma, non-small cell lung cancer 2015 2014
Blinatumomab Blincyto CD19, CD3; Murine bispecific tandem scFv Acute lymphoblastic leukemia 2015 2014
Pembrolizumab Keytruda PD1; Humanized IgG4 Melanoma 2015 2014
Ramucirumab Cyramza VEGFR2; Human IgG1 Gastric cancer 2014 2014
Vedolizumab Entyvio α4β7 integrin; Humanized IgG1 Ulcerative colitis, Crohn disease 2014 2014
Siltuximab Sylvant IL-6; Chimeric IgG1 Castleman disease 2014 2014
Obinutuzumab Gazyva CD20; Humanized IgG1; Glycoengineered Chronic lymphocytic leukemia 2014 2013
Ado-trastuzumab emtansine Kadcyla HER2; Humanized IgG1, ADC Breast cancer 2013 2013
Raxibacumab (Pending) B. anthrasis PA; Human IgG1 Anthrax infection NA 2012
Pertuzumab Perjeta HER2; Humanized IgG1 Breast Cancer 2013 2012
Brentuximab vedotin Adcetris CD30; Chimeric IgG1, ADC Hodgkin lymphoma, systemic anaplastic large cell lymphoma 2012 2011
Belimumab Benlysta BLyS; Human IgG1 Systemic lupus erythematosus 2011 2011
Ipilimumab Yervoy CTLA-4; Human IgG1 Metastatic melanoma 2011 2011
Denosumab Prolia RANK-L; Human IgG2 Bone Loss 2010 2010
Tocilizumab RoActemra, Actemra IL-6R; Humanized IgG1 Rheumatoid arthritis 2009 2010
Ofatumumab Arzerra CD20; Human IgG1 Chronic lymphocytic leukemia 2010 2009
Canakinumab Ilaris IL-1β; Human IgG1 Muckle-Wells syndrome 2009 2009
Golimumab Simponi TNF; Human IgG1 Rheumatoid and psoriatic arthritis, ankylosing spondylitis 2009 2009
Ustekinumab Stelara IL-12/23; Human IgG1 Psoriasis 2009 2009
Certolizumab pegol Cimzia TNF; Humanized Fab, pegylated Crohn disease 2009 2008
Catumaxomab Removab EPCAM/CD3;Rat/mouse bispecific mAb Malignant ascites 2009# NA
Eculizumab Soliris C5; Humanized IgG2/4 Paroxysmal nocturnal hemoglobinuria 2007 2007
Ranibizumab Lucentis VEGF; Humanized IgG1 Fab Macular degeneration 2007 2006
Panitumumab Vectibix EGFR; Human IgG2 Colorectal cancer 2007 2006
Natalizumab Tysabri a4 integrin; Humanized IgG4 Multiple sclerosis 2006 2004
Bevacizumab Avastin VEGF; Humanized IgG1 Colorectal cancer 2005 2004
Cetuximab Erbitux EGFR; Chimeric IgG1 Colorectal cancer 2004 2004
Efalizumab Raptiva CD11a; Humanized IgG1 Psoriasis 2004# 2003#
Omalizumab Xolair IgE; Humanized IgG1 Asthma 2005 2003
Tositumomab-I131 Bexxar CD20; Murine IgG2a Non-Hodgkin lymphoma NA 2003#
Ibritumomab tiuxetan Zevalin CD20; Murine IgG1 Non-Hodgkin lymphoma 2004 2002
Adalimumab Humira TNF; Human IgG1 Rheumatoid arthritis 2003 2002
Alemtuzumab MabCampath, Campath-1H; Lemtrada CD52; Humanized IgG1 Chronic myeloid leukemia#; multiple sclerosis 2013;
2001#
2014;
2001#
Gemtuzumab
ozogamicin
Mylotarg CD33; Humanized IgG4, ADC Acute myeloid leukemia 2018 2017;
2000#
Trastuzumab Herceptin HER2; Humanized IgG1 Breast cancer 2000 1998
Infliximab Remicade TNF; Chimeric IgG1 Crohn disease 1999 1998
Palivizumab Synagis RSV; Humanized IgG1 Prevention of respiratory syncytial virus infection 1999 1998
Basiliximab Simulect IL-2R; Chimeric IgG1 Prevention of kidney transplant rejection 1998 1998
Daclizumab Zenapax; Zinbryta IL-2R; Humanized IgG1 Prevention of kidney transplant rejection; multiple sclerosis 2016;
1999#
2016;
1997#
Rituximab MabThera, Rituxan CD20; Chimeric IgG1 Non-Hodgkin lymphoma 1998 1997
Abciximab Reopro GPIIb/IIIa; Chimeric IgG1 Fab Prevention of blood clots in angioplasty 1995* 1994
Edrecolomab Panorex EpCAM; Murine IgG2a Colorectal cancer 1995*# NA
Nebacumab Centoxin Endotoxin; Human IgM Gram-negative sepsis 1991*# NA
Muromonab-CD3 Orthoclone Okt3 CD3; Murine IgG2a Reversal of kidney transplant rejection 1986* 1986#

Source: Janice M. Reichert, PhD, The Antibody Society.

Table notes: *, Country-specific approval. #, Withdrawn or marketing discontinued for the first approved indication. NA, not approved or in review in the EU; not approved or information on review status not available in US.

Additional notes:

1. Of the antibody therapeutics listed in the table, the following products were not first approved in the EU or US:
Satralizumab (Enspryng), first approved in Canada in May 2020;
Risankizumab
, first approved in Japan in March 2019;
Romosozumab, first approved in Japan on January 8, 2019;
Sarilumab, first approved in Canada on January 12, 2017;
Brodalumab, first approved in Japan on July 4, 2016;
Secukinumab, first approved in Japan on December 26, 2014;
Mogamulizumab, first approved in Japan on March 30, 2012;
Tocilizumab, first approved in Japan on April 11, 2005;
Cetuximab, first approved in Switzerland on December 1, 2003.

2. Several antibody therapeutics are approved for marketing in regions other than the EU or US. These products include:
Nimotuzumab (TheraCIM®, BIOMAB-EGFR®), humanized anti-EGFR IgG1 approved in numerous countries for various forms of solid tumors starting in the 2000s.

Itolizumab (Alzumab), humanized anti-CD6 IgG1 approved in India in January 2013 for psoriasis.
RabiMabs (Twinrab TM), mixture of 2 anti-rabies virus mAbs approved in India in 2019
Rmab (RabiShield), human anti-rabies virus G glycoprotein IgG1 approved in India in 2016 for post-exposure prophylaxis of rabies.

Sintilimab (Tyvyt), human anti-PD-1 mAb approved in China in December 2018 for Hodgkin’s lymphoma.
Toripalimab (Tuoyi), humanized anti-PD-1 mAb approved in China in December 2018 for melanoma.
Camrelizumab, humanized anti-PD-1 mAb approved in China in 2019 for Hodgkin’s lymphoma;
Tislelizumab, humanized anti-PD-1 mAb, approved in China in December 2019 as a treatment for classical Hodgkin’s lymphoma

Netakimab, anti-IL-17 mAb approved in Russia in 2019 for plaque psoriasis.
Prolgolimab (Forteca), anti-PD-1 mAb approved in Russia in 2020 for melanoma.
Olokizumab (Artlegia), anti-IL-6 humanized IgG4 approved in Russia in 2020 for rheumatoid arthritis.
Levilimab (Ilsira) anti-IL-6R human mAb approved in Russia in 2020 for COVID-19.

In addition,  the antibody therapeutic vaccine Vaxira® (racotumomab, 1 E 10; murine IgG1 kappa) is approved in Argentina and Cuba. It is an anti-idiotypic monoclonal antibody that induces an immune response against glycolylated gangliosides (NeuGcGM3) present in tumor cells. Originally developed in Cuba at the Center of Molecular Immunology, Vaxira® is marketed in Argentina and Cuba for the treatment of recurrent or advanced non-small cell lung cancer (NSCLC), or NSCLC independent of the disease stage when no other standard therapy can be administered for lung cancer.

References:
Kaplon H, et al. Antibodies to watch in 2020. MAbs. Vol. 12. doi.org/10.1080/19420862.2019.1703531.
Kaplon H, Reichert JM. Antibodies to watch in 2019. MAbs. 2019 Feb/Mar;11(2):219-238. doi: 10.1080/19420862.2018.1556465.
Kaplon H, Reichert JM. Antibodies to watch in 2018. 2018;10(2):183-203. doi: 10.1080/19420862.2018.1415671.
Reichert JM. Antibodies to watch in 2017. MAbs. 2017;9(2):167-181. doi: 10.1080/19420862.2016.1269580.
Reichert JM. Antibodies to watch in 2016. MAbs. 2016;8(2):197-204. doi: 10.1080/19420862.2015.1125583.
Ecker DM, Jones SD, Levine HL. The therapeutic monoclonal antibody market. MAbs. 2015;7(1):9-14. doi: 10.4161/19420862.2015.989042.
Reichert JM. Marketed therapeutic antibodies compendium. MAbs. 2012 May-Jun;4(3):413-5. doi: 10.4161/mabs.19931

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