Whether it’s a pioneering antibody like OKT3, or an effective financially attainable biosimilar, each approved antibody plays an important role in the quest to improve patient health. By our estimation, as of September 2019, 107 antibodies have been approved in the US and/or Europe since OKT3 in 1986. These antibodies cover a wide range of indications (see table below). Worldwide antibody sales are expected to reach nearly $115 billion by 2022*. The current rate of approval by the FDA is 4 antibodies per year. It’s important to note that of the 107 monoclonal antibodies that have been approved by the FDA and EMA, the vast majority (roughly 86%) have been discovered via hybridoma based technologies (with a small but growing portion from transgenic human antibody-producing animals). That’s quite a track record for what many consider to be an “old” technology!
Approved Monoclonal Antibody Products
| Trade Name | International Non-proprietary Name | Company | Target | Therapeutic Indication(s) | Year of FDA Approval |
| Xevudy® | Sotrovimab | Vir Biotechnology and GlaxoSmithKline | Spike-protein | SARS-CoV-2 | EMA (2021) |
| Regkirona | Regdanvimab | Celltrion | Spike-protein | SARS-CoV-2 | EMA (2021) |
| Ronapreve/REGEN-COV | Casirivimab & Imdevimab | Regeneron Pharmaceuticals | Spike-protein | SARS-CoV-2 | In review |
| Tezpire™ | Tezepelumab-ekko | Amgen and AstraZeneca | Thymic stromal lymphopoietin | Severe asthma | 2021 |
| Tivdak™ | Tisotumab vedotin-tftv | Seagen and Genmab | Tissue factor | Cervical cancer | 2021 |
| Rybrevant™ | Amivantamab-vmjw | Janssen (Johnson and Johnson) | EGFR and cMET | Non-small cell lung cancer (NSCLC) | 2021 |
| Saphnelo™ | Anifrolumab-fnia | AstraZeneca | IFNAR1 | Systemic lupus erythematosus (SLE) | 2021 |
| Zynlonta® | Loncastuximab tesirine-lpyl | ADC Therapeutics | CD19 | Diffuse large B-cell lymphoma (DLBCL) | 2021 |
| Bimzelx® | Bimekizumab | UCB | IL-17A | Plaque psoriasis | EMA (2021) |
| Adbry™/Adtralza® | Tralokinumab-ldrm | Leo Pharma | IL-13 | Atopic dermatitis | 2021 |
| Evkeeza™ | Evinacumab-dngnb | Regeneron Pharmaceuticals | Angiopoietin-like 3 | Homozygous familial hypercholesterolemia | 2021 |
| Aduhelm® | Aducanumab-avwa | Biogen | Amyloid beta | Alzheimer’s disease | 2021 |
| Jemperli | Dostarlimab-gxly | GlaxoSmithKline | PD-1 | Endometrial cancer | 2021 |
| Ebanga™ | Ansuvimab-zykl | Ridgeback Biotherapeutics | Zaire ebolavirus glycoprotein 1 (GP1) | Ebola virus | 2020 |
| Margenza™ | Margetuximab-cmkb | MacroGenics | HER2 | Metastatic breast cancer | 2020 |
| Danyelza® | Naxitamab-gqgk | Y-mAbs Therapeutics | GD2 | Neuroblastoma | 2020 |
| Inmazeb™ | Atoltivimab/Maftivimab/Odesivimab-ebgn | Regeneron Pharmaceuticals | Zaire ebolavirus glycoprotein | Ebola virus | 2020 |
| Enspryng™ | Satralizumab-mwge | Genentech (Roche) | IL-6R | Neuromyelitis optica spectrum disorder (NMOSD) | 2020 |
| Blenrep® | Belantamab mafodotin-blmf | GlaxoSmithKline | BCMA | Multiple myeloma | 2020 |
| Monjuvi® | Tafasitamab-cxix | Morphosys | CD19 | Diffuse large B-cell lymphoma (DLBCL) | 2020 |
| Uplizna™ | Inebilizumab-cdon | Viela Bio | CD19 | Neuromyelitis optica spectrum disorder (NMOSD) | 2020 |
| Trodelvy™ | Sacituzumab govitecan-hziy | Immunomedics (Gilead) | Trop-2 | Triple-negative breast cancer (TNBC) | 2020 |
| Sarclisa® | Isatuximab-irfc | Sanofi | CD38 | Multiple myeloma | 2020 |
| Vyepti™ | Eptinezumab-jjmr | Alder BioPharmaceuticals (Lundbeck) | CGRP | Migraine | 2020 |
| Tepezza® | Teprotumumab-trbw | Horizon Therapeutics | IGF-1R | Thyroid eye disease | 2020 |
| Enhertu® | Fam-trastuzumab deruxtecan-nxki | Daiichi Sankyo | HER2 | Breast cancer | 2019 |
| Padcev™ | Enfortumab vedotin-ejfv | Astellas Pharma and Seattle Genetics | Nectin-4 | Locally advanced or metastatic urothelial cancer (mUC) | 2019 |
| Adakveo® | Crizanlizumab-tmca | Novartis | P-selectin | Sickle cell disease | 2019 |
| Beovu® | Brolucizumab-dbll | Novartis | VEGF-A | Macular degeneration | 2019 |
| Polivy™ | Polatuzumab vedotin-piiq | Genentech (Roche) | CD79b | Diffuse large B-cell lymphoma (DLBCL) | 2019 |
| Skyrizi™ | Risankizumab-rzaa | Abbvie | IL-23 | Plaque psoriasis | 2019 |
| Evenity® | Romosozumab-aqqg | Amgen and UCB Pharma | Sclerostin | Osteoporosis | 2019 |
| Ultomiris™ | Ravulizumab-cwvz. | Alexion Pharmaceuticals. | Complement protein C5 | Paroxysmal nocturnal hemoglobinuria (PNH) | 2018 |
| Truxima® | Rituximab-abbs | Celltrion and Teva Pharmaceuticals | CD20 | Non-Hodgkin’s lymphoma | 2018 |
| Gamifant® | Emapalumab-lzsg | Novimmune and Swedish Orphan Biovitrum AB (Sobi) | IFNγ | Hemophagocytic lymphohistiocytosis (HLH) | 2018 |
| Ilumya™/ Illumetri® | Tildrakizumab-asmn | Sun Pharma | IL23 (p19) | Plaque psoriasis | 2018 |
| Trogarzo® | Ibalizumab-uiyk | Theratechnologies Inc | CD4 | Human immunodeficiency virus-1 (HIV-1) | 2018 |
| Libtayo® | Cemiplimab-rwlc | Sanofi | PD-1 | Advanced/metastatic cutaneous squamous cell carcinoma (CSCC) | 2018 |
| Lumoxiti™ | Moxetumomab pasudotox-tdfk | AstraZeneca | CD22 | B-lymphoblastic leukemia/lymphoma and hairy cell leukemia (HCL) | 2018 |
| Poteligeo® | Mogamulizumab-kpkc | Kyowa Hakko Kirin | CC chemokine receptor 4 (CCR4) | Mycosis fungoides (MF) or Sézary syndrome (SS) | 2018 |
| Cablivi™ | Caplacizumab-yhdp | Ablynx (Sanofi Genzyme) | von Willebrand factor (vWF) | Acquired thrombotic thrombocytopenic purpura (aTTP) | 2018 |
| Takhzyro® | Lanadelumab-flyo | Shire | Plasma kallikrein | Hereditary angioedema (HAE) | 2018 |
| Crysvita® | Burosumab-twza | Ultragenyx Pharmaceuticals and Kyowa Kirin | FGF-23 | X-linked hypophosphatemia (XLH) | 2018 |
| Emgality® | Galcanezumab-gnlm | Eli Lilly. | Calcitonin gene-related peptide (CGRP) receptor | Migraine | 2018 |
| Ajovy™ | Fremanezumab-vfrm | Teva Pharmaceuticals | Calcitonin gene-related peptide (CGRP) receptor | Migraine | 2018 |
| Aimovig® | Erenumab-aooe | Amgen | Calcitonin gene-related peptide (CGRP) receptor | Migraine | 2018 |
| Ixifi™ | Infliximab-qbtx | Pfizer | TNFα | Rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative collitis, plaque psoriasis | 2017 |
| Ogivri™ | Trastuzumab-dkst | Mylan and Biocon | HER2 | Breast cancer and metastatic gastric cancer | 2017 |
| Mvasi™ | Bevacizumab-awwb | Amgen | VEGF | Metastatic colorectal cancer; non-squamous non-small cell lung cancer; glioblastoma multiforme; metastatic renal cell carcinoma; cervical cancer | 2017 |
| Cyltezo® | Adalimumab-adbm | Boehringer Ingelheim Pharmaceuticals | TNFα | Rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative collitis, plaque psoriasis | 2017 |
| Renflexis | Infliximab-abda | Merck and Samsung Bioepis | TNFα | Rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative collitis, plaque psoriasis | 2017 |
| Hemlibra® | Emicizumab-kxwh | Chugai and Genentech (Roche) | Factor IXa and X | Hemophelia A | 2017 |
| Fasenra® | Benralizumab | MedImmune (AstraZeneca) | IL-5R | Asthma | 2017 |
| Besponsa® | Inotuzumab ozogamicin | Pfizer | CD22 | B-cell precursor acute lymphoblastic leukemia (ALL) | 2017 |
| Tremfya® | Guselkumab | Janssen (Johnson and Johnson) | IL-23 | Plaque psoriasis | 2017 |
| Kevzara® | Sarilumab | Sanofi and Regeneron Pharmaceuticals | IL-6R | Rheumatoid arthritis | 2017 |
| Bavencio® | Avelumab | Merck KGaA and Pfizer | PD-L1 | Metastatic Merkel cell carcinoma | 2017 |
| Dupixent® | Dupilumab | Regeneron Pharmaceuticals | IL-4Rα | Asthma; dermatitis | 2017 |
| Imfinzi® | Durvalumab | Astrazeneca | PD-L1 | Metastatic urothelial carcinoma | 2017 |
| Ocrevus™ | Ocrelizumab | Genentech (Roche) | CD20 | Multiple sclerosis | 2017 |
| Siliq™/ Kyntheum® | Brodalumab | Amgen and AstraZeneca | IL-17RA | Plaque psoriasis | 2017 |
| Amjevita® | Adalimumab-atto | Amgen Europe | TNFα | Arthritis; juvenile rheumatoid arthritis; psoriatic arthritis; rheumatoid colitis; ulcerative Crohn’s disease; psoriasis; spondylitis; ankylosing | 2016 |
| Zinplava™ | Bezlotoxumab | Merck Sharp & Dohme Limited | C. difficile toxin B | Enterocolitis; pseudomembranous | 2016 |
| Taltz® | Ixekizumab | Eli Lilly | IL-17A | Plaque psoriasis | 2016 |
| Cinqair™ | Reslizumab | Teva Pharmaceuticals | IL-5 | Asthma | 2016 |
| Lartruvo™ | Olaratumab | Eli Lilly | PDGFR-α | Sarcoma | 2016 |
| Inflectra™ | Infliximab-dyyb | Hospira UK Limited | TNFα | Spondylitis; ankylosing; arthritis; rheumatoid colitis; ulcerative arthritis; psoriatic Crohn’s Disease; psoriasis | 2016 |
| Anthim® | Obiltoxaximab | Elusys Therapeutics INC | PA component of B. anthracis toxin | Anthrax infection | 2016 |
| Tecentriq® | Atezolizumab | Genentech (Roche) | PD-L1 | Metastatic non-small cell lung cancer | 2016 |
| Darzalex® | Daratumumab | Janssen-Cilag | CD38 | Multiple myeloma | 2015 |
| Empliciti® | Elotuzumab | Bristol-Myers Squibb | SLAMF7 | Multiple myeloma | 2015 |
| Portrazza™ | Necitumumab | Eli Lilly | EGFR | Carcinoma, non-small-cell lung | 2015 |
| Cosentyx™ | Secukinumab | Novartis Europharm | IL-17A | Arthritis; psoriatic psoriasis; spondylitis; ankylosing | 2015 |
| Nucala® | Mepolizumab | GlaxoSmithKline | IL-5 | Asthma | 2015 |
| Opdivo® | Nivolumab | Bristol-Myers Squibb | PD-1 | Carcinoma; non-small-cell lung carcinoma; renal cell Hodgkin disease melanoma | 2015 |
| Praluent® | Alirocumab | Sanofi-Aventis Group | PCSK9 | Dyslipidemias | 2015 |
| Praxbind® | Idarucizumab | Boehringer Ingelheim International GmbH | Dabigatran | Hemorrhage (inactivating oral anticoagulant dabigatran; dabigatran etexilate prodrug) | 2015 |
| Repatha® | Evolocumab | Amgen | LDL-C / PCSK9 | Dyslipidemias; hypercholesterolemia | 2015 |
| Unituxin® | Dinutuximab | United Therapeutics Europe | GD2 | Neuroblastoma | 2015 |
| Entyvio® | Vedolizumab | Takeda Pharma | Integrin-α4β7 | Colitis; ulcerative Crohn’s disease | 2015 |
| Blincyto® | Blinatumomab | Amgen Europe | CD19 | Precursor cell lymphoblastic leukemia-lymphoma | 2014 |
| Keytruda® | Pembrolizumab | Merck Sharp & Dohme Limited | PD-1 | Melanoma, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), head and neck squamous cell cancer (HNSCC), Hodgkin lymphoma, urothelial carcinoma, GI tract cancers | 2014 |
| Cyramza® | Ramucirumab | Eli Lilly | VEGF | Stomach neoplasms | 2014 |
| Sylvant® | Siltuximab | Janssen-Cilag International | cCLB8 | Giant lymph node hyperplasia, Castleman’s disease | 2014 |
| Lemtrada® | Alemtuzumab | Sanofi | CD52 | Multiple sclerosis (relapsing-remitting) | 2014 |
| Kadcyla® | Trastuzumab emtansine | Roche | HER2 | Breast Cancer | 2013 |
| Remsima® | Infliximab | Celltrion Healthcare | TNFα | Spondylitis; ankylosing arthritis; rheumatoid colitis; ulcerative Crohn’s disease; arthritis; psoriatic psoriasis | EMA (2013) |
| Gazyva®/ Gazyvaro® | Obinutuzumab | Roche | CD20 | Chronic Lymphocytic leukemia (CLL) | 2013 |
| Perjeta® | Pertuzumab | Roche | HER2 | Breast Cancer | 2012 |
| ABthrax® | Raxibacumab | HGS (Human Genome Sciences Inc.) | Bacillus anthracis protective antigen | Prevention and treatment of inhalation anthrax | 2012 |
| Adcetris® | Brentuximab vendotin MMAE | Seattle Genetics | CD30 | Hodgkin lymphoma (HL), systemic anaplastic large cell lymphoma (ALCL) | 2011 |
| Benlysta® | Belimumab | HGS and GlaxoSmithKline | BLyS | Systemic lupus erythematosus (SLE) | 2011 |
| Yervoy® | Ipilimumab | Bristol-Myers Squibb | CTLA-4 | Melanoma | 2011 |
| Prolia®/Xgeva® | Denosumab | Amgen | RANKL | Osteoporosis/Prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors | 2010/2011 |
| Arzerra® | Ofatumumab | Genmab and GlaxoSmithKline | CD20 | Chronic lymphocytic leukemia | 2009 |
| Scintimun® (Diagnostic) | 99mTc-Besilesomab | CIS Bio | NCA-95 | In vivo diagnosis of inflammation/infection sites via scintigraphic imaging (non-therapeutic) | EMA (2010) |
| Actemra® | Tocilizumab | Chugai (Roche) | IL-6 receptor | Rheumatoid arthritis | 2010 |
| Ilaris® | Canakinumab | Novartis | IL-1ß | 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) | 2009 |
| Simponi® | Golimumab | Centocor Ortho Biotech (Johnson & Johnson) | TNFα | Rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis | 2009 |
| Stelara® | Ustekinumab | Centocor Ortho Biotech (Johnson & Johnson) | IL-12/IL-23 | Psoriasis, psoriatic arthritis, Crohn’s disease, plaque psoriasis | 2009 |
| Cimzia® | Certolizumab pegol | UCB | TNFα | Chron’s disease; rheumatoid arthritis | 2008 |
| Removab® | Catumaxomab | Fresenius | EpCAM (CD326) and CD3 | Malignant ascites in patients with EpCAM-positive carcinomas | EMA (2009) |
| Soliris® | Eculizumab | Alexion Pharmaceuticals | Complement protein C5 | Paroxysmal nocturnal hemoglobinuria (PNH) | 2007 |
| Lucentis® | Ranibizumab | Genentech (Roche) | VEGF-A | Neovascular (wet) age-related macular degeneration; macular edema following retinalvein occlusion | 2006 |
| Vectibix® | Panitumumab | Abgenix (Amgen) | EGFR | Metastatic colorectal carcinoma | 2006 |
| Proxinium® | Catumaxomab | Viventia (Eleven Biotherapeutics) | EpCAM (CD326) | Head and neck cancer | 2005 |
| Tysabri® | Natalizumab | Biogen Idec and Elan | VLA-4 | Multiple sclerosis (relapsing); Crohn’s disease | 2004 |
| Avastin® | Bevacizumab | Genentech (Roche) | VEGF | Metastatic colorectal cancer; non-small cell lung cancer; metastatic breast cancer; glioblastoma multiforme; metastatic renal cell carcinoma | 2004 |
| NeutroSpec® (Diagnostic) | 99mTc-Fanolesomab | Palatin Technologies | CD15 | Imaging of equivocal appendicitis | 2004 |
| Erbitux® | Cetuximab | ImClone (Eli Lilly), Merck Serono and BMS | EGFR | Head and neck cancer; colorectal cancer | 2004 |
| Xolair® | Omalizumab | Genentech (Roche) and Novartis | IgE | Asthma | 2003 |
| Raptiva® | Efalizumab | Merck Serono, Genentech (Roche) | CD11a | Psoriasis | 2003 |
| Bexxar® | 131I-Tositumomab | Corixa and GlaxoSmithKline | CD20 | Non-Hodgkin’s lymphoma | 2003 |
| Humira® | Adalimumab | Abbott | TNFα | Rheumatoid arthritis; juvenile idiopathic arthritis; psoriatic arthritis; ankylosing spondylitis; Crohn’s disease, plaque psoriasis | 2002 |
| Zevalin® | 90Y-Ibritumomab tiuxetan | Biogen Idec | CD20 | Non-Hodgkin’s lymphoma | 2002 |
| Campath® | Alemtuzumab | Millennium Pharmaceuticals and Genzyme | CD52 | B-cell chronic lymphocyte leukemia | 2001 |
| Mylotarg® | Gemtuzumab ozogamicin | Wyeth | CD33 | Acute myeloid leukemia (AML) | 2000 |
| Herceptin® | Trastuzumab | Genentech (Roche) | HER-2 | Breast cancer; metastatic gastric or gastroesophageal junction adenocarcinoma | 1998 |
| Remicade® | Infliximab | Centocor Ortho Biotech (Johnson & Johnson) | TNFα | Crohn’s disease; ulcerative colitis; rheumatoid arthritis; ankylosing spondylitis; psoriatic arthritis; plaque psoriasis | 1998 |
| Synagis® | Palivizumab | MedImmune, Abbot | F-protein of RS virus | Respiratory syncytial virus (RSV) | 1998 |
| Simulect® | Basiliximab | Novartis | CD25 (a chain of IL2 receptor) | Reversal of transplantation rejection | 1998 |
| HumaSPECT® (Diagnostic) | 99mTc-Votumumab | Oragnon Teknica | Cytokeratin tumor-associated antigen | Detection of colorectal cancer | EMA (1998) |
| Zenapax®/Zinbryta® | Daclizumab | Biogen | CD25 (a chain of IL2 receptor) | Zinbryta® for Multiple Sclerosis, Zenapax® for acute transplant rejection | 1997 |
| Rituxan®/MabThera® | Rituximab | Biogen Idec Pharmaceuticals, Genentech (Roche) | CD20 | Non-Hodgkin’s lymphoma; chronic lymphocytic leukemia; rheumatoid arthritis | 1997 |
| LeukoScan® (Diagnostic) | 99mTc-Sulesomab | Immunomedics | NCA90 | Diagnostic imaging of forosteomyelitis | EMA (1997) |
| CEA-scan® (Diagnostic) | 99mTc-Arcitumomab | Immunomedics | Human CEA (carcinoembryonic antigen) | Detection of colorectal cancer | 1996 |
| MyoScint® (Diagnostic) | 111In-Imiciromab pentetate | Centocor Ortho Biotech (Johnson & Johnson) | Human cardiac myosin | Diagnostic imaging of myocardial infarction | 1996 |
| ProstaScint® (Diagnostic) | 111In-Capromab pendetide | Cytogen | Tumor surface antigen PSMA | Detection of prostate adenocarcinoma | 1996 |
| Verluma® (Diagnostic) | 99mTc-Nofetumomab merpentan | Boehringer Ingelheim, NeoRx | Carcinoma-associated antigen | Diagnostic imaging of small-cell lung cancer (SCLC) | 1996 |
| Tecnemab-K-1® (Diagnostic) | Antimelanoma Mab fragments | Sorin Biomedica Diagnostics | High molecular weight melanoma associated antigen (HMW-MAA) | Diagnostic imaging of cutaneous melanoma lesions | EMA (1996) |
| Indimacis 125® (Diagnostic) | 111In-Igovomab | CIS Bio International | CA125 | Diagnostic imaging of ovarian adenocarcinoma | EMA (1996) |
| Panorex® | Edrecolomab | Centocor Ortho Biotech (Johnson & Johnson), Eli Lilly | EpCAM (CD326) | Colorectal cancer | EMA (1995) |
| ReoPro® | Abciximab | Centocor Ortho Biotech (Johnson & Johnson), Eli Lilly | GPIIb/Illa | High risk angioplasty (prevention of blood clots) | 1994 |
| OncoScint® (Diagnostic) | 111In-Satumomab pendetide | Cytogen | TAG-72 | Detection of colorectal and ovarian carcinoma | 1992 |
| Centoxin® | Nebacumab | Centocor Ortho Biotech (Johnson & Johnson) | Endotoxin (HA-1A) | Gram-negative sepsis | EMA (1991) |
| Orthoclone OKT3® | Muromonab-CD3 | Centocor Ortho Biotech (Johnson & Johnson) | CD3 | Transplantation rejection | 1986 |
Marketing Approval Agencies:
Approval by the US Food and Drug Administration (FDA) grants marketing authorization in all 50 US states as well as other US territories and possession.
Approval by the European Medicines Agency (EMA) grants marketing authorization in all European Union (EU) and European Economic Area (EEA)-European Free Trade Association (EFTA) states (which include Iceland, Liechtenstein, and Norway).
If the antibody therapy was not approved by the FDA, the EMA date is indicated.
* Antibody Drugs: Technologies and Global Markets. (Jan 2019). Retrieved from Coherent Market Insights.