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 Products that were granted approvals but subsequently withdrawn from the market are included in the table.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 2024. (MAbs. Vol. 16.) includes details about antibody therapeutics that may enter regulatory review or be granted approvals in 2024. A collection of previous installments (2010-2023) of the Antibodies to Watch article series can be found here.
- Data for antibody therapeutics that were granted a first approval in regions other than the EU or US are found here.
During 2023, 10 antibody therapeutics were granted first approvals in either the US or EU.
Need detailed data for all approved antibodies, including those approved outside the US/EU?
Access a searchable table that includes data on the format, Fc modifications and cell expression systems for antibody therapeutic products that are approved or are in regulatory review in any country.
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/resources/approved-antibodies.
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 |
Telisotuzumab vedotin | (Pending) | cMET; Humanized IgG1 | Non-small cell lung cancer | NA | Review |
Nipocalimab | (Pending) | FcRn; Human IgG1 | Generalized myasthenia gravis | Review | Review |
Bentracimab | (Pending) | Ticagrelor; Human Fab | Reversal of ticagrelor’s antiplatelet effects | NA | Review |
Datopotamab deruxtecan | (Pending) | TROP-2; Humanized IgG1 ADC | Non-small cell lung cancer | Review | Review |
Zenocutuzumab | BIZENGRI® | HER2, HER3; Humanized IgG1, Bispecific | NRG1+ non-small cell lung and pancreatic cancer | NA | 2024 |
Nemolizumab | Nemluvio | IL-31R-alpha; Humanized IgG2 | Prurigo nodularis | Review | 2024 |
Zanidatamab | Ziihera® | HER2; Humanized, Biparatopic bispecific | Biliary tract cancers | Review | 2024 |
Linvoseltamab | (Pending) | BCMA, CD3; Human IgG4 | Multiple myeloma | Review | 2nd cycle review |
Axatilimab | Niktimvo | CSF-1R; Humanized IgG4 | Graft-versus-host disease | NA | 2024 |
Patritumab deruxtecan | (Pending) | HER3; Human IgG1 ADC | Non-small cell lung cancer | NA | 2nd cycle review |
Tarlatamab | IMDELLTRA | DLL, CD3; scFv-scFv-scFc bispecific | Small cell lung cancer | NA | 2024 |
Marstacimab | Hympavzi | Tissue factor pathway inhibitor; Human IgG1 | Hemophilia | 2024 | 2024 |
Garadacimab | (Pending) | Factor XIIa; Human IgG1 | Hereditary angioedema | Review | Review |
Vilobelimab | GOHIBIC | Complement C5a; Chimeric IgG4 | SARS-CoV-2 induced septic acute respiratory distress syndrome | Pos. opinion | NA |
Zolbetuximab | VYLOY | Claudin 18.2; Chimeric IgG1 | Gastric or gastroesophageal junction adenocarcinoma | 2024 | 2024 |
Odronextamab | Ordspono | CD20, CD3; Human IgG4, bispecific | Diffuse large B cell lymphoma, follicular lymphoma | 2024 | 2nd cycle review |
Crovalimab | PiaSky | Complement C5; Humanized IgG1 | Paroxysmal nocturnal hemoglobinuria | 2024 | 2024 |
Camrelizumab | AiRuiKa | PD-1; Human IgG4 | Hepatocellular carcinoma | NA | Review |
Serplulimab | Hetronifly, HANSIZHUANG | PD-1; Human IgG4 | Small cell lung cancer | Pos. opinion | NA |
Sugemalimab | Cejemly® | PD-L1; Human IgG4 | Non-small cell lung cancer | 2024 | NA |
Concizumab | Alhemo™ | Tissue factor pathway inhibitor; Humanized IgG4 | Hemophilia | Pos. opinion | 2nd cycle review |
Cosibelimab | (Pending) | PD-L1; Human IgG1 | Squamous cell carcinoma | NA | 2nd cycle review |
Trastuzumab duocarmazine | (Pending) | HER2; Humanized IgG1 ADC | Breast cancer | MAA withdrawn | 2nd cycle review |
Donanemab | Kisunla | Amyloid beta; Humanized IgG1 | Alzheimer’s disease | NA | 2024 |
Sintilimab | Tyvyt | PD-1; Human IgG4 | Non-small cell lung cancer | NA | 2nd cycle review |
Narsoplimab | (Pending) | MASP-2; Human IgG4 | Hematopoietic stem cell transplant-associated thrombotic microangiopathies | NA | 2nd cycle review |
Pozelimab | VEOPOZ | Complement 5; Human IgG4 | CHAPLE disease | NA | 2023 |
Elranatamab | Elrexfio | BCMA, CD3; Humanized IgG2 | Multiple myeloma | 2023 | 2023 |
Rozanolixizumab | RYSTIGGO® | FcRn; Humanized IgG4 | Generalized myasthenia gravis | 2024 | 2023 |
Talquetamab | TALVEY | G protein-coupled receptor 5D, CD3; Humanized IgG4 bispecific | Multiple myeloma | 2023 | 2023 |
Epcoritamab | EPKINLY™ | CD20, CD3; Bispecific humanized IgG1 | Diffuse large B cell lymphoma | 2023 | 2023 |
Lebrikizumab | Ebglys | IL-13; humanized IgG4 | Atopic dermatitis | 2023 | 2024 |
Glofitamab | Columvi® | CD20, CD3e; Bispecific 2+1 IgG1 CrossMab | Diffuse large B-cell lymphoma | 2023 | 2023 |
Mirikizumab | Omvoh | IL-23p19;Humanized IgG4 | Ulcerative colitis | 2023 | 2023 |
Tislelizumab | TEVIMBRA | PD-1; Humanized IgG4 | Esophageal squamous cell carcinoma | 2023 | 2024 |
Toripalimab | LOQTORZI, Tuoyi | PD-1; Humanized IgG4 | Nasopharyneal carcinoma, esophageal squamous cell carcinoma | 2024 | 2023 |
Retifanlimab | Zynyz | PD-1; Humanized IgG4 | Merkel cell carcinoma | 2024 | 2023 |
Lecanemab | Leqembi | Amyloid beta protofibrils; Humanized IgG1 | Alzheimer’s disease | Review | 2023 |
Teplizumab | TZIELD | CD3; Humanized IgG1 | Delay onset of type 1 diabetes | NA | 2022 |
Ublituximab | BRIUMVI | CD20; Chimeric IgG1 | Multiple sclerosis | 2023 | 2022 |
Mirvetuximab soravtansine | ELAHERE | Folate receptor alpha; Humanized IgG1 ADC | Ovarian cancer | 2024 | 2022 |
Nirsevimab | Beyfortus | RSV; Human IgG1 | RSV infection | 2022 | 2023 |
Tremelimumab | Imjudo | CTLA-4; Human IgG2A | Antineoplastic; liver cancer | 2023 | 2022 |
Spesolimab | SPEVIGO® | IL-36 receptor; Humanized IgG1 | Generalized pustular psoriasis | 2022 | 2022 |
Teclistamab | TECVAYLI | BCMA, CD3; Humanized bispecific IgG4 | Multiple myeloma | 2022 | 2022 |
Mosunetuzumab | Lunsumio | CD20, CD3; Humanized bispecific IgG1 | Follicular lymphoma | 2022 | 2022 |
Tixagevimab, cilgavimab | Evusheld | SARS-CoV-2; Human IgG1 | COVID-19 | 2022 | EUA |
Relatlimab | Opdualag (relatlimab + nivolumab combo) | LAG-3; Human IgG4 | Melanoma | 2022 | 2022 |
Tebentafusp | KIMMTRAK | gp100, CD3; Bispecific immunoconjugate (TCR-scFv) | Metastatic uveal melanoma | 2022 | 2022 |
Faricimab | Vabysmo | VEGF-A, Ang-2; Human/humanized IgG1 kappa/lambda, with domain crossover | wAMD, DME | 2022 | 2022 |
Sutimlimab | Enjaymo | C1s; Humanized IgG4 | Cold agglutinin disease | 2022 | 2022 |
Sotrovimab | Xevudy | SARS-CoV-2; Human IgG1 | COVID-19 | 2021 | 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 | EUA |
Tezepelumab | Tezspire | Thymic stromal lymphopoietin; Human IgG2 | Severe asthma | 2022 | 2021 |
Tisotumab vedotin | TIVDAK | Tissue factor; Human IgG1 ADC | Cervical cancer | Review | 2021 |
Amivantamab | Rybrevant | EGFR, cMET; Human bispecific IgG1 | NSCLC w/ EGFR exon 20 insertion mutations | 2021 | 2021 |
Anifrolumab | Saphnelo | IFNAR1; Human IgG1 | Systemic lupus erythematosus | 2022 | 2021 |
Loncastuximab tesirine | Zynlonta | CD19; Humanized IgG1 ADC | Diffuse large B-cell lymphoma | 2022 | 2021 |
Bimekizumab | Bimzelx | IL-17A,F; Humanized IgG1 | Psoriasis | 2021 | 2023 |
Tralokinumab | Adtralza | IL-13; Human IgG4 | Atopic dermatitis | 2021 | 2021 |
Evinacumab | Evkeeza | Angiopoietin-like 3; Human IgG4 | Homozygous familial hypercholesterolemia | 2021 | 2021 |
Aducanumab | Aduhelm | Amyloid beta; Human IgG1 | Alzheimer’s disease | MAA withdrawn | 2021 |
Dostarlimab | Jemperli | PD-1; Humanized IgG4 | Endometrial cancer | 2021 | 2021 |
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 | 2022 | 2020 |
Sacituzumab govitecan | Trodelvy | TROP-2; Humanized IgG1 ADC | Triple-neg. breast cancer | 2021 | 2020 |
Teprotumumab | Tepezza | IGF-1R; Human IgG1 | Thyroid eye disease | Review | 2020 |
Isatuximab | Sarclisa | CD38; Chimeric IgG1 | Multiple myeloma | 2020 | 2020 |
Eptinezumab | Vyepti | CGRP; Humanized IgG1 | Migraine prevention | 2022 | 2020 |
[fam]-trastuzumab deruxtecan | Enhertu | HER2; Humanized IgG1 ADC | HER2+ breast cancer | 2021 | 2019 |
Enfortumab vedotin | Padcev | Nectin-4; Human IgG1 ADC | Urothelial cancer | 2022 | 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 | 2024 Pos. opinion; 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# |
Patritumab deruxtecan(Pending)HER3; Human IgG1 ADCNon-small cell lung cancerNAReviewTarlatamab(Pending)DLL, CD3; scFv-scFv-scFc bispecificSmall cell lung cancerNAReviewMarstacimab(Pending)Tissue factor pathway inhibitor; Human IgG1HemophiliaReviewReviewGaradacimab(Pending)Factor XIIa; Human IgG1Hereditary angioedemaReviewNAZolbetuximab(Pending)Claudin 18.2; Chimeric IgG1Gastric or gastroesophageal junction adenocarcinomaReviewReviewOdronextamab(Pending)CD20, CD3; Human IgG4, bispecificDiffuse large B cell lymphoma, follicular lymphomaReviewReviewCamrelizumab(Pending)PD-1; Human IgG4Hepatocellular carcinomaNAReviewSerplulimab(Pending)PD-1; Human IgG4Small cell lung cancerReviewNASugemalimab(Pending)PD-L1; Human IgG4Non-small cell lung cancerReviewNAConcizumabAlhemo™Tissue factor pathway inhibitor; Humanized IgG4HemophiliaReview2nd cycle reviewCosibelimab(Pending)PD-L1; Human IgG1Squamous cell carcinomaNA2nd cycle reviewTrastuzumab duocarmazine(Pending)HER2; Humanized IgG1 ADCBreast cancerMAA withdrawn2nd cycle reviewDonanemab(Pending)Amyloid beta Humanized IgG1Alzheimer’s diseaseNA2nd cycle reviewSintilimab(Pending)PD-1; Human IgG4Non-small cell lung cancerNA2nd cycle reviewNarsoplimab
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 Japan in July 2021.
Casirivimab and imdevimab (Ronapreve), anti-SARS-CoV-2 antibody approved in Australia in Oct 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:
“Antibodies to watch” article collection published in mAbs. Starting in 2010, the ‘Antibodies to Watch’ article series has documented the commercial clinical pipeline of antibody therapeutics by reporting details of antibodies in late-stage clinical studies, candidate products in regulatory review, and recent approvals of novel mAb therapeutics. All articles are open access.
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