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 Products that were granted approvals but subsequently withdrawn from the market are included in the table.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.
- Antibodies to watch in 2021. (MAbs. Vol. 13. doi.or/10.1080/19420862.2020.1860476) includes details about antibody therapeutics that may enter regulatory review or be granted approvals in 2021.
- Antibody therapeutics that were granted a first approval in regions other than the EU or US are listed at the end of the table below.
As of Nov 12, 2021, 18 investigational antibody therapeutics are in regulatory review in either the US or EU.
During January 1 to Nov 12, 2021, 11 antibody therapeutics were granted first approvals in either the US or EU.
Interested in more than the basics? Access a searchable table that includes detailed data on the format, Fc modifications and cell expression systems for antibody therapeutic products.
Please cite our data as follows:
The Antibody Society. Therapeutic monoclonal antibodies approved or in review in the EU or US. (date accessed); www.antibodysociety.org.
Download an Excel file of the data shown in the table below.
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 |
| Spesolimab | (Pending) | IL-36 receptor; Humanized IgG1 | Generalized pustular psoriasis | Review | NA |
| Regdanvimab | Regkirona | SARS-CoV-2; Human IgG1 | COVID-19 | 2021 | NA |
| Casirivimab + imdevimab | REGEN-COV, Ronapreve | SARS-CoV-2; Human IgG1 | COVID-19 | 2021 | Review |
| Lecanemab | (Pending) | Amyloid beta protofibrils; Humanized IgG1 | Alzheimer’s disease | NA | Review |
| Relatlimab | (Pending) | LAG-3; Human IgG4 | Melanoma | NA | Review |
| Tebentafusp | (Pending) | gp100, CD3; Bispecific immunoconjugate (TCR-scFv) | Metastatic uveal melanoma | Review | Review |
| Faricimab | (Pending) | VEGF-A, Ang-2; Human/humanized IgG1 kappa/lambda, with domain crossover | wAMD, DME | Review | Review |
| Tislelizumab | (Pending) | PD-1; Humanized IgG4 | Esophageal squamous cell carcinoma | NA | Review |
| Penpulimab | (Pending) | PD-1; Humanized IgG1 | Metastatic nasopharyngeal carcinoma | NA | Review |
| Sintilimab | (Pending) | PD-1; Human IgG4 | Non-small cell lung cancer | NA | Review |
| Teplizumab | (Pending) | CD3; Humanized IgG1 | Type 1 diabetes | NA | Review |
| Tezepelumab | (Pending) | Thymic stromal lymphopoietin; Human IgG2 | Severe asthma | Review | Review |
| Toripalimab | Tuoyi | PD-1; Humanized IgG4 | Nasopharyneal carcinoma | NA | Review |
| Omburtamab | (Pending) | B7-H3; Murine IgG1 | CNS/leptomeningeal metastasis from neuroblastoma | Review | NA |
| Tisotumab vedotin | TIVDAK | Tissue factor; Human IgG1 ADC | Cervical cancer | NA | 2021 |
| Retifanlimab | (Pending) | PD-1; Humanized IgG4 | Squamous cell carcinoma of the anal canal | Review | Review |
| Sutimlimab | (Pending) | C1s; Humanized IgG4 | Cold agglutinin disease | NA | Review |
| Ublituximab | (Pending) | CD20; Chimeric IgG1 | Chronic lymphocytic leukemia | NA | Review |
| Amivantamab | Rybrevant | EGFR, cMET; Human bispecific IgG1 | NSCLC w/ EGFR exon 20 insertion mutations | Review | 2021 |
| Anifrolumab | Saphnelo | IFNAR1; Human IgG1 | Systemic lupus erythematosus | Review | 2021 |
| Loncastuximab tesirine | Zynlonta | CD19; Humanized IgG1 ADC | Diffuse large B-cell lymphoma | NA | 2021 |
| Bimekizumab | Bimzelx | IL-17A,F; Humanized IgG1 | Psoriasis | 2021 | Review |
| Tralokinumab | Adtralza | IL-13; Human IgG4 | Atopic dermatitis | 2021 | Review |
| Evinacumab | Evkeeza | Angiopoietin-like 3; Human IgG4 | Homozygous familial hypercholesterolemia | 2021 | 2021 |
| Aducanumab | Aduhelm | Amyloid beta; Human IgG1 | Alzheimer’s disease | Review | 2021 |
| Dostarlimab | Jemperli | PD-1; Humanized IgG4 | Endometrial cancer | 2021 | 2021 |
| 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, Minjuvi | CD19; Humanized IgG1 | Diffuse large B-cell lymphoma | 2021 | 2020 |
| Satralizumab | Enspryng | IL-6R; Humanized IgG2 | Neuromyelitis optica and neuromyelitis optica spectrum disorders | 2021 | 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 | 2021 | 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 | 2021 | 2019 |
| Enfortumab vedotin | Padcev | Nectin-4; Human IgG1 ADC | Urothelial cancer | Review | 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 | 2021 | 2018 |
| Galcanezumab | Emgality | CGRP; Human IgG4 | Migraine prevention | 2018 | 2018 |
| Lanadelumab | Takhzyro | Plasma kallikrein; Human IgG1 | Hereditary angioedema attacks | 2018 | 2018 |
| Mogamulizumab | 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 | Qarziba; Unituxin | GD2; Chimeric IgG1 | Neuroblastoma | 2017; 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
Disitamab vedotin (Aidixi), anti-HER2 humanized ADC approved in China in June 2021 as a treatment for gastric cancer;
Penpulimab, ant-PD-1 humanized mAb approved in China in August 2021 for Hodgkin’s lymphoma;
Zimberelimab, anti-PD-1 human mAb approved in China in August 2021 for 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.
Cetuximab saratolacan sodium, anti-EGFR mAb approved in Japan in September 2020 for head and neck cancer.
Pabinafusp alfa (IZCARO), anti-transferrin receptor inmmunoconjuate approve in Japan in March 2021 for Hunter syndrome.
Sotrovimab, anti-SARS-CoV-2 antibody approved in Australia in August 2021.
Regdanvimab, anti-SARS-CoV-2 antibody approved in the Republic of Korea in September 2021.
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, Reichert JM. Antibodies to watch in 2021. MAbs. Vol. 13. doi.or/10.1080/19420862.2020.1860476.
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
