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, 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 Products that were granted approvals but subsequently withdrawn from the market are included in the table. The European public assessment reports for human medicines published by the European Medicines Agency (EMA), and information about pending European Commission decisions and medicines under evaluation can be found via the EMA’s ‘Find medicine’  page. Information about therapeutics approved in the US can be found at Drugs@FDA. Antibody therapeutics that were granted a first approval in any region other than the EU or US are listed at the end of the table.

An Excel file of the data can be downloaded here.
Biosimilar products are excluded.

Therapeutic monoclonal antibodies approved or in review in the EU or the US.

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 #, Withdrawn or marketing discontinued for the first approved indication.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:
Romosozumab, first approved in Japan
Sarilumab, first approved in Canada on January 12, 2017;
Brodalumab, first approved in Japan on July 4, 2016;
Secukinumab, first approved in Japan in December 2014;
Tocilizumab, first approved in Japan in 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.
Mogamulizumab (POTELIGEO®), humanized anti-CCR4 IgG1 first approved in Japan on March 30, 2012 for relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma.
Itolizumab (Alzumab), humanized anti-CD6 IgG1 approved in India in January 2013 for psoriasis.
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, humanized anti-PD-1 mAb approved in China in December 2018 for melanoma.
Netakimab, anti-IL-17 mAb approved in Russia in 2019 for plaque psoriasis.
RabiMabs (Twinrab TM), mixture of 2 anti-rabies virus mAbs approved in India in 2019
Tislelizumab, approved by the China National Medical Products Administration as a treatment for patients with classical Hodgkin’s lymphoma in December 2019.

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:
Kaplon H, et al. Antibodies to watch in 2020. MAbs. Vol. 12. doi.org/10.1080/19420862.2019.1703531.
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Kaplon H, Reichert JM. Antibodies to watch in 2018. 2018;10(2):183-203. doi: 10.1080/19420862.2018.1415671.
Reichert JM. Antibodies to watch in 2017. MAbs. 2017;9(2):167-181. doi: 10.1080/19420862.2016.1269580.
Reichert JM. Antibodies to watch in 2016. MAbs. 2016;8(2):197-204. doi: 10.1080/19420862.2015.1125583.
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