Antibody therapeutics approved or in regulatory review in the EU or US

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 Products that were granted approvals but subsequently withdrawn from the market are included in the table.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.

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