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 Products that were granted approvals but subsequently withdrawn from the market are included in the table.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

• 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 regions other than the EU or US are listed at the end of the table.

Click here to download an Excel file of the data.

As of October 14, 9 antibody therapeutics had been granted first approvals in the US in 2020, and an additional 16 are in regulatory review.

Therapeutic monoclonal antibodies approved or in review in the EU or 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 #, Withdrawn or marketing discontinued for the first approved indication.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:
Satralizumab (Enspryng), first approved in Canada in May 2020;
Risankizumab, first approved in Japan in March 2019;
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;
Mogamulizumab, first approved in Japan in March 2012;
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.

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

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.

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.
Kaplon H, Reichert JM. Antibodies to watch in 2019. MAbs. 2019 Feb/Mar;11(2):219-238. doi: 10.1080/19420862.2018.1556465.
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.
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