Table 1.
US FDA-approved monoclonal antibody on the market
| mAb | Brand name | Company | Target | Format | Technology | Indication& | US# Approval |
|---|---|---|---|---|---|---|---|
| Muromonab-CD3 | Orthoclone OKT3 | Centocor Ortho Biotech Products LP. | CD3 | Murine IgG2a | Hybridoma/Janssen Biotech, Inc | Kidney transplant rejection | 1986* |
| Abciximab | Reopro | Centocor Inc./Eli Lilly/Janssen Biotech Inc. | GPIIb/IIIa | Chimeric IgG1 Fab | Hybridoma | Prevention of blood clots in angioplasty | 1994 |
| Rituximab | MabThera, Rituxan | Biogen Inc./Roche, F. Hoffmann-La Roche Ltd./Genentech Inc. | CD20 | Chimeric IgG1 | Hybridoma | Non-Hodgkin lymphoma | 1997 |
| Palivizumab | Synagis | MedImmune/AbbVie Inc. | RSV | Humanized IgG1 | Hybridoma | Prevention of respiratory syncytial virus infection | 1998 |
| Infliximab | Remicade | Janssen Biotech Inc. | TNFα | Chimeric IgG1 | Hybridoma | Crohn’s disease | 1998 |
| Trastuzumab | Herceptin | Roche, F. Hoffmann-La Roche, Ltd./Genentech Inc. | HER2 | Humanized IgG1 | Hybridoma | Breast cancer | 1998 |
| Alemtuzumab | Campath, Lemtrada | Berlex Inc./Genzyme Corp./Millennium Pharmaceuticals Inc. | CD52 | Humanized IgG1 | Hybridoma | Chronic myeloid leukemia | 2001 |
| Adalimumab | Humira | AbbVie Inc. | TNFα | Human IgG1 | Phage display | Rheumatoid arthritis | 2002 |
| Ibritumomab tiuxetan | Zevalin | Biogen Inc./Schering AG/Spectrum Pharmaceuticals Inc. | CD20 | Murine IgG1 | Hybridoma | Non-Hodgkin lymphoma | 2002 |
| Omalizumab | Xolair | Roche, F. Hoffmann-La Roche, Ltd./Genentech Inc./Novartis Pharmaceuticals Corp./Tanox Inc. | IgE | Humanized IgG1 | Hybridoma | Asthma | 2003 |
| Cetuximab | Erbitux | Bristol-Myers Squibb/Merck & Co. Inc./Eli Lilly/ImClone Systems Inc. | EGFR | Chimeric IgG1 | Hybridoma | Colorectal cancer | 2004 |
| Bevacizumab | Avastin | Roche, F. Hoffmann-La Roche, Ltd./Genentech Inc. | VEGF-A | Humanized IgG1 | Hybridoma | Colorectal cancer | 2004 |
| Natalizumab | Tysabri | Biogen Inc./Elan Pharmaceuticals International, Ltd. | ITGA4 | Humanized IgG4 | Hybridoma | Multiple sclerosis | 2004 |
| Panitumumab | Vectibix | Amgen | EGFR | Human IgG2 | Transgenic mice | Colorectal cancer | 2006 |
| Ranibizumab | Lucentis | Roche, F. Hoffmann-La Roche Ltd./Genentech Inc./Novartis Pharmaceuticals Corp. | VEGF-A | Humanized IgG1 Fab | Hybridoma | Macular degeneration | 2006 |
| Eculizumab | Soliris | Alexion Pharmaceuticals Inc. | C5 | Humanized IgG2/4 | Hybridoma | Paroxysmal nocturnal hemoglobinuria | 2007 |
| Certolizumab pegol | Cimzia | Celltech, UCB. | TNFα | Humanized Fab, pegylated | Hybridoma | Crohn’s disease | 2008 |
| Ustekinumab | Stelara | Medarex/Centocor Ortho Biotech Inc./Janssen Biotech Inc. | IL-12/23 | Human IgG1 | Transgenic mice | Psoriasis | 2009 |
| Canakinumab | Ilaris | Novartis Pharmaceuticals Corp. | IL-1β | Human IgG1 | Transgenic mice | Muckle-Wells syndrome | 2009 |
| Golimumab | Simponi | Centocor Ortho Biotech Inc./Janssen Biotech Inc. | TNFα | Human IgG1 | Transgenic mice | Rheumatoid and psoriatic arthritis, ankylosing spondylitis | 2009 |
| Ofatumumab | Arzerra | Genmab A/S /GlaxoSmithKline /Novartis. | CD20 | Human IgG1 | Transgenic mice | Chronic lymphocytic leukemia | 2009 |
| Tocilizumab | RoActemra, Actemra | Chugai Pharmaceutical Co., Ltd./Roche, F. Hoffmann-La Roche. Ltd./Genentech Inc. | IL-6R | Humanized IgG1 | Hybridoma | Rheumatoid arthritis | 2010 |
| Denosumab | Xgeva, Prolia | Amgen | RANKL | Human IgG2 | Transgenic mice | Bone loss | 2010 |
| Belimumab | Benlysta | GlaxoSmithKline /Human Genome Sciences Inc. | BLyS | Human IgG1 | Phage display | Systemic lupus erythematosus | 2011 |
| Ipilimumab | Yervoy | Bristol-Myers Squibb/Medarex | CTLA-4 | Human IgG1 | Transgenic mice | Metastatic melanoma | 2011 |
| Brentuximab vedotin | Adcetris | Seattle genetics Inc./Takeda Pharmaceutical Co., Ltd. | CD30 | Chimeric IgG1; ADC | Hybridoma | Hodgkin lymphoma, systemic anaplastic large cell lymphoma | 2011 |
| Pertuzumab | Perjeta | Roche, F. Hoffmann-La Roche, Ltd./Genentech Inc. | HER2 | Humanized IgG1 | Hybridoma | Breast Cancer | 2012 |
| Trastuzumab emtansine | Kadcyla | Roche, F. Hoffmann-La Roche Ltd./Genentech Inc./ImmunoGen Inc. | HER2 | Humanized IgG1; ADC | Hybridoma | Breast cancer | 2012 |
| Raxibacumab | Abthrax | GlaxoSmithKline /Human Genome Sciences Inc. (HGSI) | B. anthrasis PA | Human IgG1 | Transgenic mice | Anthrax infection | 2012 |
| Obinutuzumab | Gazyva, Gazyvaro | Biogen Inc./Roche, F. Hoffmann-La Roche, Ltd./Genentech Inc. | CD20 | Humanized IgG1 Glycoengineered | Hybridoma | Chronic lymphocytic leukemia | 2013 |
| Siltuximab | Sylvant | Centocor Inc./Janssen Biotech Inc./Janssen-Cilag International NV | IL-6 | Chimeric IgG1 | Hybridoma | Castleman disease | 2014 |
| Ramucirumab | Cyramza | Eli Lilly/ImClone Systems Inc. | VEGFR2 | Human IgG1 | Phage display | Gastric cancer | 2014 |
| Vedolizumab | Entyvio | Genentech Inc./Millennium Pharmaceuticals Inc./Takeda Pharmaceuticals U.S.A. Inc. | α4β7 integrin | Humanized IgG1 | Hybridoma | Ulcerative colitis, Crohn disease | 2014 |
| Blinatumomab | Blincyto | Amgen | CD19, CD3 | Murine bispecific tandem scFv | Hybridoma | Acute lymphoblastic leukemia | 2014 |
| Nivolumab | Opdivo | Bristol-Myers Squibb/Ono Pharmaceutical Co., Ltd. | PD-1 | Human IgG4 | Transgenic mice | Melanoma, non-small cell lung cancer | 2014 |
| Pembrolizumab | Keytruda | Merck & Co. Inc. | PD-1 | Humanized IgG4 | Hybridoma | Melanoma | 2014 |
| Idarucizumab | Praxbind | Boehringer Ingelheim Pharmaceuticals | Dabigatran | Humanized Fab | Hybridoma | Reversal of dabigatran-induced anticoagulation | 2015 |
| Necitumumab | Portrazza | Eli Lilly/ImClone Systems Inc. | EGFR | Human IgG1 | Phage display | Non-small cell lung cancer | 2015 |
| Dinutuximab | Unituxin | United Therapeutics Corporation | GD2 | Chimeric IgG1 | Hybridoma | Neuroblastoma | 2015 |
| Secukinumab | Cosentyx | Novartis Pharmaceuticals Corp. | IL-17α | Human IgG1 | Transgenic mice | Psoriasis | 2015 |
| Mepolizumab | Nucala | Centocor Inc./GlaxoSmithKline | IL-5 | Humanized IgG1 | Hybridoma | Severe eosinophilic asthma | 2015 |
| Alirocumab | Praluent | Regeneron Pharmaceuticals Inc./Sanofi. | PCSK9 | Human IgG1 | Transgenic mice | High cholesterol | 2015 |
| Evolocumab | Repatha | Amgen/Amgen Astellas BioPharma K.K. | PCSK9 | Human IgG2 | Transgenic mice | High cholesterol | 2015 |
| Daratumumab | Darzalex | Genmab A/S/Janssen Biotech Inc. | CD38 | Human IgG1 | Transgenic mice | Multiple myeloma | 2015 |
| Elotuzumab | Empliciti | Bristol-Myers Squibb/AbbVie Inc. | SLAMF7 | Humanized IgG1 | Hybridoma | Multiple myeloma | 2015 |
| Ixekizumab | Taltz | Eli Lilly | IL-17α | Humanized IgG4 | Hybridoma | Psoriasis | 2016 |
| Reslizumab | Cinqaero, Cinqair | Celltech, UCB/Schering-Plough/Teva Pharmaceutical Industries, Ltd. | IL-5 | Humanized IgG4 | Hybridoma | Asthma | 2016 |
| Olaratumab | Lartruvo | Eli Lilly/ImClone Systems Inc. | PDGFRα | Human IgG1 | Transgenic mice | Soft tissue sarcoma | 2016 |
| Bezlotoxumab | Zinplava | Merck & Co. Inc. | Clostridium difficile enterotoxin B | Human IgG1 | Transgenic mice | Prevention of Clostridium difficile infection recurrence | 2016 |
| Atezolizumab | Tecentriq | Roche, F. Hoffmann-La Roche, Ltd./Genentech Inc. | PD-L1 | Humanized IgG1 | Hybridoma | Bladder cancer | 2016 |
| Obiltoxaximab | Anthim | Elusys Therapeutics Inc. | B. anthrasis PA | Chimeric IgG1 | Hybridoma | Prevention of inhalational anthrax | 2016 |
| Inotuzumab ozogamicin | Besponsa | Wyeth Pharmaceuticals/Pfizer. | CD22 | Humanized IgG4 | Hybridoma | Acute lymphoblastic leukemia | 2017 |
| Brodalumab | Siliq, Lumicef | MedImmune/Amgen/Kyowa Hakko Kirin /AstraZeneca/Valeant Pharmaceuticals International Inc. | IL-17R | Human IgG2 | Transgenic mice | Plaque psoriasis | 2017 |
| Guselkumab | Tremfya | MorphoSys/Janssen Biotech Inc. | IL-23 p19 | Human IgG1 | Phage display | Plaque psoriasis | 2017 |
| Dupilumab | Dupixent | Regeneron Pharmaceuticals Inc./Sanofi | IL-4Rα | Human IgG4 | Transgenic mice | Atopic dermatitis | 2017 |
| Sarilumab | Kevzara | Regeneron Pharmaceuticals Inc./Sanofi | IL-6R | Human IgG1 | Transgenic mice | Rheumatoid arthritis | 2017 |
| Avelumab | Bavencio | Merck Serono International S.A./Pfizer | PD-L1 | Human IgG1 | Phage display | Merkel cell carcinoma | 2017 |
| Ocrelizumab | Ocrevus | Biogen Inc./Roche, F. Hoffmann-La Roche, Ltd./Genentech Inc./SIGMA-TAU Industrie Farmaceutiche Riunite S.p.A. | CD20 | Humanized IgG1 | Hybridoma | Multiple sclerosis | 2017 |
| Emicizumab | Hemlibra | Chugai Pharmaceutical Co., Ltd./Roche, F. Hoffmann-La Roche, Ltd. | Factor IXa, X | Humanized IgG4, bispecific | Hybridoma | Hemophilia A | 2017 |
| Benralizumab | Fasenra | MedImmune/Kyowa Hakko Kirin/AstraZeneca | IL-5Rα | Humanized IgG1 | Hybridoma | Asthma | 2017 |
| Gemtuzumab ozogamicin | Mylotarg | Pfizer | CD33 | Humanized IgG4; ADC | Hybridoma | Acute myeloid leukemia | 2017 |
| Durvalumab | Imfinzi | MedImmune/AstraZeneca | PD-L1 | Human IgG1 | Transgenic mice | Bladder cancer | 2017 |
| Burosumab | Crysvita | Kyowa Hakko Kirin/Ultragenyx Pharmaceutical Inc. | FGF23 | Human IgG1 | Transgenic mice | X-linked hypophosphatemia | 2018 |
| Lanadelumab | Takhzyro | Dyax Corp. | Plasma kallikrein | Human IgG1 | Phage display | Hereditary angioedema attacks | 2018 |
| Mogamulizumab | Poteligeo | Kyowa Hakko Kirin | CCR4 | Humanized IgG1 | Hybridoma | Mycosis fungoides or Sézary syndrome | 2018 |
| Erenumab | Aimovig | Novartis | CGRPR | Human IgG2 | Transgenic mice | Migraine prevention | 2018 |
| Galcanezumab | Emgality | Eli Lilly | CGRP | Humanized IgG4 | Hybridoma | Migraine prevention | 2018 |
| Tildrakizumab | Ilumya | Merck & Co. Inc./Sun Pharmaceutical Industries, Ltd. | IL-23 p19 | Humanized IgG1 | Hybridoma | Plaque psoriasis | 2018 |
| Cemiplimab | Libtayo | Regeneron Pharmaceuticals Inc. | PD-1 | Human mAb | Transgenic mice | Cutaneous squamous cell carcinoma | 2018 |
| Emapalumab | Gamifant | NovImmmune | IFNγ | Human IgG1 | Phage display | Primary hemophagocytic lymphohistiocytosis | 2018 |
| Fremanezumab | Ajovy | Teva Pharmaceutical Industries, Ltd. | CGRP | Humanized IgG2 | Hybridoma | Migraine prevention | 2018 |
| Ibalizumab | Trogarzo | Taimed Biologics Inc./Theratechnologies Inc. | CD4 | Humanized IgG4 | Hybridoma | HIV infection | 2018 |
| Moxetumomab pasudodox | Lumoxiti | MedImmune/AstraZeneca | CD22 | Murine IgG1 dsFv | Phage display | Hairy cell leukemia | 2018 |
| Ravulizumab | Ultomiris | Alexion Pharmaceuticals Inc. | C5 | humanized IgG2/4 | Hybridoma | Paroxysmal nocturnal hemoglobinuria | 2018 |
| Caplacizumab | Cablivi | Ablynx | von Willebrand factor |
Humanized Nanobody |
Hybridoma | Acquired thrombotic thrombocytopenic purpura | 2019 |
| Romosozumab | Evenity | Amgen/UCB | Sclerostin | Humanized IgG2 | Hybridoma | Osteoporosis in postmenopausal women at increased risk of fracture | 2019 |
| Risankizumab | Skyrizi | Boehringer Ingelheim Pharmaceuticals/ AbbVie Inc. | IL-23 p19 | Humanized IgG1 | Hybridoma | Plaque psoriasis | 2019 |
| Polatuzumab vedotin | Polivy | Roche, F. Hoffmann-La Roche, Ltd. | CD79β | Humanized IgG1 ADC | Hybridoma | Diffuse large B-cell lymphoma | 2019 |
| Brolucizumab | Beovu | Novartis Pharmaceuticals Corp. | VEGF-A | Humanized scFv | Hybridoma$ | Macular degeneration | 2019 |
| Crizanlizumab | Adakveo | Novartis Pharmaceuticals Corp. | P-selectin | Humanized IgG2 | Hybridoma | Sickle cell disease | 2019 |
*Marketing end date on July 30th, 2011
#Year of the first US FDA approval
&Indication of the first US FDA approval
$Rabbit hybridoma technology