Approved Therapeutics

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!

Therapeutic Highlight: CAMPATH-1H

Approved Monoclonal Antibody Products

Trade Name International Non-proprietary Name     Company Target Therapeutic Indication(s) Year of FDA Approval
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.