EMA recommends approval of four bevacizumab biosimilars

Biosimilars/News | Posted 12/03/2021 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 29 January 2021 that it had recommended granting marketing authorization for the bevacizumab biosimilars Alymsys and Oyavas. Then on 26 February 2021, the agency announced that it had recommended approval of the bevacizumab biosimilars Abevmy and Lextemy.

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Alymsys (BEVZ92) is produced by mAbxience, a subsidiary of Spanish healthcare firm Insud Pharma (formerly the Chemo Group). BEVZ92 has also been approved in Argentina under the brand name Bevax [1].

Oyavas is produced by German generics giant Stada Arzneimittel (Stada). Stada in-licensed the bevacizumab biosimilar from mAbxience in 2014 [2].

Both Abevmy and Lextemy (MYL-1402O) are produced by US-based Mylan (now Viatris). It has been a long road for the company, which launched Abevmy in India back in November 2017. The company also had the application for its bevacizumab biosimilar accepted by the US Food and Drug Administration (FDA) in February 2020 [3]. However, Mylan’s partner Biocon, announced in December 2020 that the application for MYL-1402O had been delayed. This is due to travel restrictions related to COVID-19 that are preventing inspection of the manufacturing facility, which is required as part of the standard review process.

The CHMP recommended at its meetings held on 25–29 January 2021 and on 22–25 February 2021 that the four bevacizumab biosimilars receive a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer and carcinoma of the cervix.

These recommendations bring the number of bevacizumab biosimilars to be approved in Europe up to 73 [4].

The positive opinion for the bevacizumab biosimilars will now be referred to the European Commission, which grants marketing authorizations for medicines in the European Union.

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To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

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Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

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1. GaBI Online - Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America 
2. GaBI Online - Generics and Biosimilars Initiative. Stada to in-license adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/News/Stada-to-in-license-adalimumab-biosimilar 
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for Mylan’s bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Mylan-s-bevacizumab-biosimilar 
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Biocon, EMA, Mylan

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