List of approved therapeutic antibodies.
| Name | Format | Target | Indication | Approval |
|---|---|---|---|---|
| Muromonab* | FL-Body | CD3 | Organ transplant rejection (heart, liver, kidney) | FDA (1986);EMA (1986);CECMED (1989);NMPA (1999) |
| IOR-T3 | FL-Body | CD3 | Organ transplant rejection | CECMED (1989);NMPA (1999) |
| Nebacumab* | Poly-Body | CD3 | Gram-negative sepsis | EMA (1991) |
| (99m Tc) Fanolesomab | Poly-Body:Conjugate | CD15 | Scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis | FDA (2004) |
| Edrecolomab* | FL-Body | EpCAM | Colorectal cancer | EMA (1995) |
| Abciximab | Frag-Body | GPIIb/IIIa | Blood clotting | FDA (1994);EMA (1995) |
| Daclizumab* | FL-Body | IL-2R (CD25) | Organ transplant rejection, multiple sclerosis | FDA (1997);EMA (1999) |
| Rituximab | FL-Body | CD20 | Rheumatoid arthritis, lymphocytic leukemia, follicular lymphoma, non-Hodgkin’s lymphoma, systemic scleroderma | FDA (1997);EMA (1998);PMDA (2001);NMPA (2000);CDSCO (2002) |
| Infliximab | FL-Body | TNF-alpha | Crohnʼs disease, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, Behcet’s disease, ulcerative colitis (UC), plaque psoriasis, Kawasaki disease | FDA (1998);EMA (1998);NMPA(2006);PMDA (2002);CDSCO (2013) |
| Trastuzumab | FL-Body | HER2 | Breast and gastric cancer | FDA (1998);EMA (1998);CDSCO (2012) |
| Palivizumab | FL-Body | RSV-F | Prevention of respiratory syncytial viral infection | FDA (1998);EMA (1999) |
| Basiliximab | FL-Body | IL-2R (CD25) | Organ (kidney, liver) transplant rejection | FDA (1998);EMA (1998);PMDA (2002);NMPA (2004);CDSCO (1999) |
| Etanercept | Frag-Body | TNF-alpha | Psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, plaque psoriasis | FDA (1998);EMA (2000);PMDA (2005);NMPA (2010);CDSCO (2012) |
| (99m Tc) Arcitumomab | Frag-Body:Conjugate | Carcinoembryonic antigen (CEA) | Diagnosis of CEA expression in cancer | FDA (1999) |
| Gemtuzumab ozogamicin | FL-Body:Conjugate | CD33 | Acute myelogenous leukemia | FDA (2017);PMDA (2005);EMA (2018); |
| Wut3 | FL-Body | CD3 | Organ transplant rejection | NMPA (2010) |
| Alemtuzumab | FL-Body | CD52 | Lymphocytic leukemia, multiple sclerosis | FDA (2001);EMA (2001);PMDA (2014) |
| Adalimumab | FL-Body | TNF-alpha | Ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, IBD | FDA (2002);EMA (2003);PMDA (2008);NMPA (2010);CDSCO (2014) |
| Ibritumomab tiuxetan | FL-Body:Conjugate | CD20 | Non-Hodgkin’s lymphoma, relapsed or refractory, low-grade or follicular NHL | FDA (2002);EMA (2004);CDSCO (2017) |
| Tositumomab-I131* | FL-Body:Conjugate | CD20 | Non-Hodgkin lymphoma | FDA (2003) |
| Omalizumab | FL-Body | IgE | Allergic asthma, urticaria | FDA (2003);EMA (2005);PMDA (2006);CDSCO (2015);NMPA (2017) |
| Efalizumab* | FL-Body | Integrin subunit alpha L (ITGAL) or CD11a | Psoriasis | FDA (2003);EMA (2004) |
| Anti-IL-8 monoclonal antibody (ENBOKE) | FL-Body | IL-8 | Atopic dermatitis, pustular psoriasis | NMPA (2003) |
| Alefacept* | Frag-Body | CD2 | Psoriasis | FDA (2003) |
| Cetuximab | FL-Body | EGFR | Colorectal, head and neck cancer | FDA (2004);EMA (2004);PMDA (2008);NMPA (2020);CDSCO (2006) |
| Bevacizumab | FL-Body | VEGF-A | Colorectal, breast, cervical, liver, ovarian, renal cancer | FDA (2004);EMA (2005);CDSCO (2005);PMDA (2007);NMPA (2010) |
| Natalizumab | FL-Body | Integrin subunit alpha 4 (ITGA4) | Multiple sclerosis, Crohn’s disease | FDA (2004);EMA (2006);PMDA (2014);CDSCO (2018) |
| Tocilizumab | FL-Body | IL-6R | Rheumatoid arthritis, Castleman’s disease, vasculitis, drug hypersensitivity, SARS-CoV-2, scleroderma | FDA (2010);EMA (2009);PMDA (2005);CDSCO (2009);NMPA (2013) |
| Abatacept | Frag-Body | CD80, CD86 | Psoriatic arthritis, rheumatoid arthritis, graft versus host disease | FDA (2005);EMA (2007);PMDA (2010);NMPA (2020) |
| Panitumumab | FL-Body | EGFR | Colorectal cancer | FDA (2006);EMA (2007);PMDA (2010);CDSCO (2017) |
| I131 derlotuximab biotin | FL-Body:Conjugate | DNA/Histone H1 | Lung cancer | NMPA (2006) |
| I131 metuximab | Frag-Body:Conjugate | CD147 | Liver cancer | NMPA (2006) |
| Nimotuzumab | FL-Body | EGFR | Head & neck cancer, anaplastic astrocytoma, brain & esophageal cancer, glioma | CECMED (2006);CDSCO (2006);NMPA (2012) |
| Ranibizumab | Frag-Body | VEGF-A | Macular degeneration, choroidal neovascularization, diabetic macular edema, diabetic retinopathy | FDA (2006);EMA (2007);PMDA (2009);NMPA (2010);CDSCO (2007) |
| Eculizumab | FL-Body | C5 | Paroxysmal nocturnal hemoglobinuria, myasthenia gravis, neuromyelitis optica, hemolytic uremic syndrome | FDA (2007);EMA (2007);PMDA (2010);NMPA (2018) |
| Rilonacept | Frag-Body | IL-1 | Cryopyrin-associated periodic syndrome, an inborn genetic disorder, pericarditis | FDA (2008) |
| Certolizumab pegol | Frag-Body:Conjugate | TNF-alpha | Psoriatic arthritis, rheumatoid arthritis, Crohn’s disease, and ankylosing spondylitis | FDA (2008);EMA (2009);PMDA (2012);NMPA (2019) |
| Romiplostim | Frag-Body | Thrombopoietin receptor (TPOR) | Aplastic anemia, acute radiation syndrome, idiopathic thrombocytopenic purpura | FDA (2008);EMA (2009);PMDA (2011);NMPA (2022) |
| Canakinumab | FL-Body | IL-1β | Muckle-wells syndrome, adult-onset still’s disease, gouty arthritis, rheumatoid arthritis | FDA (2009);EMA (2009);PMDA (2011);CDSCO (2011) |
| Catumaxomab* | Poly-Body | CD3/EpCAM | Malignant ascites | EMA (2009) |
| Ustekinumab | FL-Body | IL-12/23 | Psoriatic, IBD | FDA (2009);EMA (2009);PMDA (2011);NMPA (2017) |
| Ofatumumab | FL-Body | CD20 | Chronic lymphocytic leukemia, multiple sclerosis | FDA (2009);EMA (2010);PMDA (2013);NMPA (2021);CDSCO (2016) |
| Golimumab | FL-Body | TNF-alpha | Rheumatoid and psoriatic arthritis, ankylosing spondylitis, UC, axial spondyloarthritis | FDA (2009);EMA (2009);PMDA (2011);CDSCO (2014);NMPA (2017) |
| Denosumab | FL-Body | RANKL | Bone loss, rheumatoid arthritis, bone metastases, bone cancer, malignant hypercalcaemia, osteoporosis | FDA (2010);EMA (2010);PMDA (2012);CDSCO (2017);NMPA (2019) |
| Brentuximab vedotin | FL-Body:Conjugate | CD30 | Hodgkin lymphoma, large T-cell lymphoma, Sezary syndrome, Mycosis fungoides, | FDA (2011);EMA (2012);PMDA (2014);NMPA (2020) |
| Belatacept | Frag-Body | CD80, CD86 | Renal transplant rejection | FDA (2011);EMA (2011);CDSCO (2012) |
| Aflibercept | Frag-Body | VEGF | Colorectal cancer, retinal vein occlusion, diabetic macular edema, diabetic retinopathy, macular edema | FDA (2011);EMA (2012);PMDA (2012);NMPA (2018) |
| Belimumab | FL-Body | BAFF | Systemic lupus erythematosus, lupus nephritis | FDA (2011);EMA (2011);PMDA (2017);NMPA (2022) |
| Ipilimumab | FL-Body | CTLA-4 | Metastatic melanoma, liver cancer, renal cell carcinoma, mesothelioma, non-small cell lung cancer | FDA (2011);EMA (2011);PMDA (2015);NMPA (2021) |
| Pertuzumab | FL-Body | HER2 | Breast cancer | FDA (2012);EMA (2013);PMDA (2013);NMPA (2018) |
| Raxibacumab | FL-Body | Bacillus anthracis protective antigen | Anthrax infection | FDA (2012) |
| Mogamulizumab | FL-Body | CCR4 | Mycosis fungoides, T-cell lymphoma | FDA (2018);PMDA (2012);EMA (2018) |
| Trastuzumab emtansine | FL-Body:Conjugate | HER2 | Breast cancer | FDA (2013);EMA (2013);NMPA (2020);PMDA (2013) |
| Obinutuzumab | FL-Body | CD20 | Chronic lymphocytic leukemia, follicular lymphoma, non-Hodgkin’s lymphoma | FDA (2013);EMA (2014);PMDA (2018);NMPA (2021) |
| Conbercept | Frag-Body | VEGF | Macular degeneration | NMPA (2013) |
| Itolizumab | FL-Body | CD6 | CRS (cytokine release syndrome), plaque psoriasis, SARS-CoV 2 | CDSCO (2013) |
| Blinatumomab | Poly-Body | CD19/CD3 | Acute lymphoblastic leukemia | FDA (2014);EMA (2015);PMDA (2018);NMPA (2020) |
| Pembrolizumab | FL-Body | PD-1 | Breast, cervical, colorectal, esophageal, gastric, liver, head & neck, lung, pancreatic, urogenital, cancer, and B-cell lymphoma, Hodgkin’s lymphoma, malignant lymphoma | FDA (2014);EMA (2015);PMDA (2016);CDSCO (2016);NMPA (2018) |
| Eftrenonacog alfa | Frag-Body | Factor IX | Hemophilia B | FDA (2014);PMDA (2014);EMA (2016);NMPA (2021) |
| Vedolizumab | FL-Body | α4β7 integrin | Inflammatory bowel disease | FDA (2014);EMA (2014);CDSCO (2016);PMDA (2018) |
| Secukinumab | FL-Body | IL-17A | Psoriasis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis | FDA (2015);EMA (2015);PMDA (2014);CDSCO (2015);NMPA (2019) |
| Ramucirumab | FL-Body | VEGFR-2 | Liver, gastric, colorectal, and non-small cell lung cancer | FDA (2014);EMA (2014);PMDA (2015);CDSCO (2016);NMPA (2022) |
| Efmoroctocog alfa | Frag-Body | Factor VIII (FVIII) | Hemophilia A | FDA (2014);EMA (2015);PMDA (2014) |
| Siltuximab | FL-Body | IL-6 | Multicentric Castleman’s disease | FDA (2014);EMA (2014);NMPA (2021);CDSCO (2016) |
| Nivolumab | FL-Body | PD-1 | Melanoma, non-small cell lung cancer, colorectal cancer, esophageal cancer, gastric cancer, Hodgkin’s lymphoma, renal carcinoma, head and neck cancer, mesothelioma | FDA (2014);EMA (2015);PMDA (2014);CDSCO (2016);NMPA (2019) |
| Elotuzumab | FL-Body | SLAMF7 (SLAM family member 7) | Multiple myeloma | FDA (2015);EMA (2016);PMDA (2016) |
| Alirocumab | FL-Body | PCSK9 (Proprotein convertase subtilisin/kexin type 9) | High cholesterol, hyperlipoproteinemia type IIa | FDA (2015);EMA (2015);PMDA (2016) |
| Axicabtagene ciloleucel | Frag-Body | CD19 | Large B-cell lymphoma (LBCL) | FDA (2022);EMA (2015) |
| Mepolizumab | FL-Body | IL-5 | Asthma | FDA (2015);EMA (2015);PMDA (2016);CDSCO (2018);NMPA (2021) |
| Necitumumab | FL-Body | EGFR | Non-small cell lung cancer | FDA (2015);EMA (2016);PMDA (2019) |
| Idarucizumab | Frag-Body | Dabigatran | Reversal of dabigatran-induced anticoagulation | FDA (2015);EMA (2015);PMDA (2016);NMPA (2018);CDSCO (2017) |
| Dinutuximab | Frag-Body | GD2 | Neuroblastoma | FDA (2015);EMA (2015);PMDA (2021);NMPA (2021) |
| Daratumumab | FL-Body | CD38 | Multiple myeloma | FDA (2015);EMA (2016);PMDA (2017);CDSCO (2017);NMPA (2019) |
| Evolocumab | FL-Body | PCSK9 | Hypercholesterolemia, hyperlipoproteinemia, coronary artery disease, stroke | FDA (2015);EMA (2015);PMDA (2016);CDSCO (2017);NMPA (2018) |
| Atezolizumab | FL-Body | PD-L1 | Bladder, liver, lung, urogenital cancer | FDA (2016);EMA (2017);CDSCO (2017);PMDA (2018);NMPA (2020) |
| Olaratumab* | FL-Body | PDGFRA | Soft tissue sarcoma | FDA (2016);EMA (2016) |
| Bezlotoxumab | FL-Body | Clostridium difficile Toxin B | Prevention of C. difficile infection recurrence | FDA (2016);EMA (2017);PMDA (2017) |
| Ixekizumab | FL-Body | IL-17A | Plaque psoriasis, psoriatic arthritis, pustular psoriasis, non-radiographic axial spondyloarthritis | FDA (2016);EMA (2016);PMDA (2016);NMPA (2019) |
| Brodalumab | FL-Body | IL-17R | Plaque psoriasis, psoriatic arthritis, pustular psoriasis, axial spondylarthritis, erythrodermic psoriasis | FDA (2017);EMA (2017);PMDA (2016);NMPA (2020) |
| SII rmab | FL-Body | Rabies virus GP | Post-exposure prophylaxis of rabies | CDSCO (2016) |
| Reslizumab | FL-Body | IL-5 | Asthma | FDA (2016);EMA (2016) |
| Obiltoxaximab | FL-Body | B. anthracis PA | Anthrax infection | FDA (2016);EMA (2020) |
| Inotuzumab ozogamicin | FL-Body:Conjugate | CD22 | Hematological malignancy | FDA (2017);EMA (2017);PMDA (2018);CDSCO (2018);NMPA (2021) |
| Sarilumab | FL-Body | IL-6R | Rheumatoid arthritis | FDA (2017);EMA (2017);PMDA (2017);HC (2017) |
| Dupilumab | FL-Body | IL-4R alpha | Atopic dermatitis, eosinophilic esophagitis, asthma, nasal polyps | FDA (2017);EMA (2017);PMDA (2018);NMPA (2020) |
| Durvalumab | FL-Body | PD-L1 | Bladder cancer, lung cancer | FDA (2017);EMA (2018);PMDA (2018);NMPA (2019) |
| Idecabtagene vicleucel | Frag-Body | BCMA | Refractory multiple myeloma | FDA (2021) |
| Avelumab | FL-Body | PD-L1 | Merkel cell carcinoma, renal cell carcinoma, urogenital cancer | FDA (2017);EMA (2017);PMDA (2017) |
| Emicizumab | Poly-Body | Factor IXa/X | Hemophilia A | FDA (2017);CDSCO (2018);EMA (2018);PMDA (2018);NMPA (2018) |
| Benralizumab | FL-Body | IL-5R alpha subunit | Asthma | FDA (2017);EMA (2018);PMDA (2018) |
| Ocrelizumab | FL-Body | CD20 | Multiple sclerosis | FDA (2017);EMA (2018) |
| Guselkumab | FL-Body | IL-23p19 subunit | Plaque psoriasis, psoriatic arthritis, palmoplantar pustulosis, erythrodermic psoriasis, generalized pustular psoriasis | FDA (2017);EMA (2017);PMDA (2018);NMPA (2019) |
| Erenumab | FL-Body | CGRP-R (Calcitonin gene-related peptide receptor) | Migraine prevention | FDA (2018);EMA (2018);PMDA (2021) |
| Ravulizumab | FL-Body | C5 | Paroxysmal nocturnal hemoglobinuria, myasthenia gravis, haemolytic | FDA (2018);EMA (2019);PMDA (2019) |
| Moxetumomab pasudotox* | FL-Body:Conjugate | CD22 | Hairy cell leukemia | FDA (2018);EMA (2021) |
| Fremanezumab | FL-Body | CGRP | Migraine prevention | FDA (2018);EMA (2019);PMDA (2021) |
| Sintilimab | FL-Body | PD-1 | Non-small cell lung cancer, liver cancer, gastric cancer, esophageal cancer, Hodgkin’s lymphoma | NMPA (2018) |
| Ibalizumab | FL-Body | CD4 | HIV infection | FDA (2018);EMA (2019) |
| Galcanezumab | FL-Body | CGRP | Migraine prevention, cluster headache | FDA (2018);EMA (2018);PMDA (2021) |
| Tildrakizumab | FL-Body | IL-23p19 | Plaque psoriasis | FDA (2018);EMA (2018);PMDA (2020) |
| Emapalumab | FL-Body | IFN-γ | Primary hemophagocytic lymphohistocytosis | FDA (2018);NMPA (2022) |
| Cemiplimab | FL-Body | PD-1 | Cutaneous squamous cell carcinoma, basal cell carcinoma, and non-small cell lung cancer | FDA (2018);EMA (2019) |
| Toripalimab | FL-Body | PD-1 | Nasopharyngeal carcinoma, esophageal squamous cell carcinoma, urogenital cancer, malignant melanoma | NMPA (2018);FDA (2023);EMA (2024) |
| Caplacizumab | Frag-Body | vWF (von Willebrand Factor) | Thrombotic thrombocytopenic purpura | FDA (2019);EMA (2018) |
| Lanadelumab | FL-Body | Plasma kallikrein | Hereditary angioedema attacks | FDA (2018);EMA (2018);PMDA (2022);NMPA (2020) |
| Burosumab | FL-Body | FGF23 | X-linked hypophosphatemia, osteomalacia | FDA (2018);EMA (2018);PMDA (2019);NMPA (2021) |
| Tislelizumab | FL-Body | PD-1 | Esophageal squamous cell carcinoma, liver cancer, urogenital cancer, non-small cell lung cancer, Hodgkin’s lymphoma | FDA (2024);EMA (2023);NMPA (2019) |
| Risankizumab | FL-Body | IL-23p19 | Plaque psoriasis, psoriatic arthritis, Crohn’s disease | FDA (2019);EMA (2019);PMDA (2019) |
| Trastuzumab deruxtecan | FL-Body:Conjugate | HER2 | Breast and gastric cancer | FDA (2019);EMA (2021);PMDA (2020) |
| Brolucizumab | Frag-Body | VEGF-A | Macular degeneration | FDA (2019);EMA (2020);PMDA (2020) |
| Crizanlizumab | FL-Body | P-selectin | Vaso-occlusive crisis | FDA (2019) |
| Enfortumab vedotin (PADCEV) | FL-Body:Conjugate | Nectin-4 | Urogenital cancer | FDA (2019);EMA (2022);PMDA (2021) |
| Romosozumab | FL-Body | Sclerostin | Osteoporosis in postmenopausal women at risk of fracture, male osteoporosis | FDA (2019);EMA (2019);PMDA (2019) |
| Efgartigimod alfa | Frag-Body | FcRn | Myasthenia gravis | FDA (2021);EMA (2022);PMDA (2022) |
| Camrelizumab | FL-Body | PD-1 | Advanced renal cell carcinoma, esophageal cancer, liver cancer, nasopharyngeal cancer, non-small cell lung cancer | NMPA (2019) |
| Polatuzumab vedotin | FL-Body:Conjugate | CD79b | Diffuse large B-cell lymphoma | FDA (2019);EMA (2020);PMDA (2021) |
| Luspatercept | Frag-Body | TGF-β | Beta-thalassemia, myelodysplastic syndrome | FDA (2019);EMA (2020);NMPA (2022) |
| Rabimabs | Poly-Body | Rabies virus GP (glycoprotein) | Rabies virus infection | CDSCO (2019) |
| Netakimab | FL-Body | IL-17A | Plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis | MoH RF (2019) |
| Racotumomab | FL-Body | NeuGcGM3 | Recurrent or advanced non-small cell lung cancer | CECMED (2013);ANMAT (2013) |
| Pabinafusp alfa | FL-Body:Conjugate | Transferrin receptor | Mucopolysaccharidosis II | PMDA (2021) |
| Inebilizumab | FL-Body | CD19 | Neuromyelitis optica and neuromyelitis optica spectrum disorders | FDA (2020);NMPA (2022);PMDA (2021) |
| Teprotumumab | FL-Body | IGF-1R (insulin-like growth factor-1 receptor) | Thyroid eye disease (Graves’ orbitopathy) | FDA (2020) |
| Sacituzumab govitecan | FL-Body:Conjugate | TROP-2 | Urogenital and breast cancer | FDA (2020);EMA (2021);NMPA (2022) |
| Atoltivimab + Odesivimab + Maftivimab (INMAZEB) | Poly-Body | Ebola virus glycoprotein | Ebola virus infection | FDA (2020) |
| Cetuximab sarotalocan | FL-Body:Conjugate | EGFR | Head and neck cancer | PMDA (2020) |
| Isatuximab | FL-Body | CD38 | Multiple myeloma | FDA (2020);EMA (2020);PMDA (2020) |
| Belantamab mafodotin | FL-Body:Conjugate | BCMA | Multiple myeloma | FDA (2025);EMA (2025) |
| Levilimab | FL-Body | IL-6R | COVID-19, rheumatoid arthritis | Russia (2020) |
| Margetuximab | FL-Body | HER2 | Breast cancer | FDA (2020) |
| Satralizumab | FL-Body | IL-6R | Neuromyelitis optica and neuromyelitis optica spectrum disorders | FDA (2020);EMA (2021);PMDA (2020);HC (2020);NMPA (2021) |
| Tafasitamab | FL-Body | CD19 | Diffuse large B-cell lymphoma | FDA (2020);EMA (2021) |
| Naxitamab | FL-Body | GD2 | High-risk neuroblastoma and refractory osteomedullary disease | FDA (2020) |
| Ansuvimab | FL-Body | Ebola virus glycoprotein | Ebola infection | FDA (2020) |
| Eptinezumab | FL-Body | CGRP | Migraine prevention | FDA (2020);EMA (2022) |
| Prolgolimab | FL-Body | PD-1 | Melanoma | Russia (2020) |
| Olokizumab | FL-Body | IL-6 | Rheumatoid arthritis, COVID-19 | Russia (2020) |
| Penpulimab | FL-Body | PD-1 | Metastatic nasopharyngeal carcinoma, non-small cell lung cancer, Hodgkin’s lymphoma | FDA (2025);NMPA (2021) |
| Dostarlimab | FL-Body | PD-1 | Endometrial cancer is a solid cancer | FDA (2021);EMA (2021) |
| Evinacumab | FL-Body | ANGPTL3 | Homozygous familial hypercholesterolemia | FDA (2021);EMA (2021) |
| Sugemalimab | FL-Body | PD-L1 | Non-small cell lung cancer | NMPA (2021) |
| Envafolimab | Frag-Body | PD-L1 | Solid tumors | NMPA (2021) |
| Telitacicept | Frag-Body | BAFF | Systemic lupus erythematosus | NMPA (2021) |
| Regdanvimab* | FL-Body | SARS-CoV-2 | COVID-19 infection | EMA (2021);ANVISA (2021) |
| Amubarvimab + Romlusevimab | Poly-Body | SARS-CoV-2 | COVID-19 infection | NMPA (2021) |
| Brexucabtagene autoleucel | Frag-Body | CD19 | Relapsed or refractory mantle cell lymphoma, acute lymphoblastic leukaemia | FDA (2020);EMA (2020) |
| Amivantamab | Poly-Body | EGFR/c-Met | Non-small cell lung cancer | FDA (2021);EMA (2021) |
| Zimberelimab | FL-Body | PD-1 | Hodgkin’s lymphoma | NMPA (2021) |
| Bimekizumab | FL-Body | IL-17A/IL-17F | Plaque psoriasis, pustular psoriasis, erythrodermic psoriasis | FDA (2023);EMA (2021);PMDA (2022) |
| Loncastuximab tesirine | FL-Body:Conjugate | CD19 | Diffuse large B-cell lymphoma | FDA (2021);EMA (2022) |
| Tisotumab vedotin | FL-Body:Conjugate | TF (tissue factor) | Cervical cancer | FDA (2021) |
| Tralokinumab | FL-Body | IL-13 | Atopic dermatitis | FDA (2021);EMA (2021) |
| Tezepelumab | FL-Body | TSLP (thymic stromal lymphopoietin) | Severe asthma | FDA (2021);EMA (2022) |
| Aducanumab | FL-Body | Amyloid beta | Alzheimer’s disease | FDA (2021) |
| Disitamab vedotin | FL-Body:Conjugate | HER2 | Gastric and urothelial cancer | NMPA (2021) |
| Sotrovimab* | FL-Body | SARS-CoV-2 | COVID-19 infection | EMA (2021);PMDA (2021) |
| Casirivimab + Imdevimab* | Poly-Body | SARS-CoV-2 | COVID-19 infection | EMA (2021) |
| Anifrolumab | FL-Body | IFNAR-1(Interferon alpha receptor-1) | Systemic lupus erythematosus | FDA (2021);EMA (2022);PMDA (2021) |
| Faricimab | Poly-Body | VEGF-A/ANG-2 | Diabetic macular edema and wet age-related macular degeneration | FDA (2022);EMA (2022);PMDA (2022) |
| Teplizumab | FL-Body | CD3 | Delayed onset of type 1 diabetes | FDA (2022);EMA (2026) |
| Cadonilimab | Poly-Body | CTLA-4/PD-1 | Cervical cancer | NMPA (2022) |
| Ublituximab | FL-Body | CD20 | Multiple sclerosis | FDA (2022);EMA (in review) |
| Ormutivimab | FL-Body | Rabies virus GP (glycoprotein) | Rabies virus prophylaxis | NMPA (2022) |
| Tisagenlecleucel (KYMRIAH) | Frag-Body | CD19 | Relapsed or refractory follicular lymphoma, ALL, DLBCL, FL | FDA (2022);EMA (2018) |
| Tremelimumab | FL-Body | CTLA-4 | Liver cancer | FDA (2022);EMA (2023);PMDA (2022) |
| Lisocabtagene maraleucel | Frag-Body | CD19 | DLBCL, PMBCL, FL3B | FDA (2021);EMA (2022) |
| Mirvetuximab soravtansine | FL-Body:Conjugate | Folate receptor alpha | Ovarian cancer | FDA (2022) |
| Spesolimab | FL-Body | IL-36R | Generalized pustular psoriasis | FDA (2022);EMA (2022) |
| Sutimlimab | FL-Body | C1s | Cold agglutinin disease and autoimmune hemolytic anemia | FDA (2022);EMA (2022) |
| Mosunetuzumab-axgb | Poly-Body | CD20/CD3 | Follicular lymphoma | FDA (2022);EMA (2022) |
| Nirsevimab | FL-Body | RSV | RSV infection | FDA (2023);EMA (2022) |
| Nemolizumab | FL-Body | IL-31RA | Atopic dermatitis | PMDA (2022);FDA (2024);EMA (2025) |
| Relatlimab + Nivolumab | Poly-Body | LAG-3/PD-1 | Melanoma | FDA (2022);EMA (2022) |
| Tixagevimab + Cilgavimab* | FL-Body | SARS-CoV-2 spike protein | Covid infection | EMA (2022) |
| Serplulimab | FL-Body | PD-1 | Solid cancer, lung cancer | NMPA (2022) |
| Teclistamab | Poly-Body | BCMA/CD3 | Multiple myeloma | FDA (2022);EMA (2022) |
| Ozoralizumab | Poly-Body | TNF-alpha/albumin | Rheumatoid arthritis | FDA (in review);PMDA (2022) |
| Tebentafusp | Poly-Body | CD3 and GP100 | Metastatic uveal melanoma | FDA (2022);EMA (2022) |
| Retifanlimab | FL-Body | PD-1 | Metastatic or recurrent locally advanced Merkel cell carcinoma | FDA (2023) |
| Lecanemab | FL-Body | Amyloid beta protofibrils | Alzheimer’s disease | FDA (2023);EMA (in review) |
| Mirikizumab | FL-Body | IL-23p19 | Inflammatory bowel disease | PMDA (2023) |
| Rozanolixizumab | FL-Body | FcRn | Myasthenia gravis | FDA (2023);EMA (2024);PMDA (2023) |
| Talquetamab | Poly-Body | GPCR- 5D and CD3 | Multiple myeloma | FDA (2023);EMA (2023) |
| Epcoritamab | Poly-Body | CD20 and CD3 | B-cell lymphoma | FDA (2023);EMA (2023) |
| Lebrikizumab | FL-Body | IL-13 | Atopic dermatitis | FDA (2024);EMA (2023) |
| Glofitamab | Poly-Body | CD20 and CD3 | B-cell lymphoma | FDA (2023);EMA (2023) |
| Elranatamab | Poly-Body | BCMA and CD3 | Multiple myeloma | FDA (2023);EMA (2023) |
| Pozelimab | FL-Body | C5 | CD55-deficient protein-losing enteropathy (CHAPLE) disease | FDA (2023) |
| Narsoplimab | FL-Body | MASP-2 | Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) | FDA (2025) |
| Donanemab | FL-Body | Amyloid beta | Alzheimer’s disease | FDA (2024);EMA (2025) |
| Cosibelimab | FL-Body | PD-L1 | Squamous cell carcinoma | FDA (2024) |
| Concizumab | FL-Body | Tissue factor pathway inhibitor (TFPI) | Hemophilia A or B | FDA (2024);EMA (2024);PMDA (2023) |
| Crovalimab | FL-Body | C5 | Paroxysmal nocturnal hemoglobinuria | FDA (2024);EMA (2024) |
| Odronextamab | Poly-Body | CD20, CD3 | Follicular lymphoma | EMA (2024) |
| Zolbetuximab | FL-Body | Claudin 18.2 | Gastroesophageal junction adenocarcinoma | FDA (2024);EMA (2024) |
| Vilobelimab | FL-Body | C5a | SARS-CoV-2-induced septic acute respiratory distress syndrome | FDA (2025) |
| Garadacimab | FL-Body | Factor XIIa | Hereditary angioedema | FDA (2025);EMA (2025) |
| Marstacimab | FL-Body | TFPI | Hemophilia | FDA (2024);EMA (2024) |
| Tarlatamab | Poly-Body | DLL3 and CD3 | Small-cell lung cancer | FDA (2025) |
| Axatilimab | FL-Body | CSF-1R | Graft-versus-host disease | FDA (2024) |
| Linvoseltamab | Poly-Body | BCMA and CD3 | Multiple myeloma | FDA (2025);EMA (2025) |
| Zanidatamab | Poly-Body | HER2 | Biliary tract cancers | FDA (2024);EMA (2025) |
| Zenocutuzumab | Poly-Body | HER2 and HER3 | NRG1+ non-small cell lung and pancreatic cancer | FDA (2024) |
| Datopotamab deruxtecan | FL-Body:Conjugate | TROP-2 | Breast cancer | FDA (2025);EMA (2025) |
| Nipocalimab | FL-Body | FcRn | Generalized myasthenia gravis | FDA (2025);EMA (2025) |
| Clesrovimab | FL-Body | RSV | RSV infection | FDA (2025) |
| Sibeprenlimab | FL-Body | APRIL | Nephropathy proteinuria | FDA (2025) |
| Telisotuzumab vedotin | FL-Body:Conjugate | cMET | Non-small cell lung cancer | FDA (2025) |
| Depemokimab | FL-Body | IL-5 | Asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps | FDA (2025) |
* Indicates antibodies withdrawn from the market due to one or more reasons such as clinical failure, loss of efficacy, severe side effects, or commercial reasons. FDA: Food and Drug Administration; EMA: European Medicines Agency; PMDA: Pharmaceuticals and Medical Devices Agency; NMPA: National Medical Products Administration; CDSCO: Central Drugs Standard Control Organization; CECMED: Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos; HC: Health Canada; MoH RF: Ministry of Health of the Russian Federation; ANMAT: National Administration of Drugs, Food and Medical Devices. FL-Bodies: full-length antibodies; Frag-Bodies: antibody fragments; Poly-Body: polyspecific and polyvalent antibody; ALL: acute lymphoblastic leukemia; DLBCL: diffuse large B-cell lymphoma; FL: follicular lymphoma; FL3B: follicular lymphoma grade 3B; NHL: non-Hodgkin lymphoma; PMBCL: primary mediastinal large B-cell lymphoma.