EC approves bevacizumab biosimilar Abevmy

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EC approves bevacizumab biosimilar Abevmy

Biosimilares/Novedades | Posted 14/05/2021 0 Post your comment

On 26 April 2021, India-based biologicals specialist Biocon Biologics (Biocon) announced that its bevacizumab biosimilar, Abevmy (MYL 1402O), which it co-developed with US-based drugmaker Viatris (formerly Mylan), had received European Commission (EC) approval.

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

The EC has approved Abevmy 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. The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 22–25 February 2021 [1].

There are already nine other bevacizumab biosimilars approved in Europe. Mvasi, produced by Amgen, was the first to be approved in January 2018 [2].

Mylan (now Viatris) also 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 EC approval is valid in all EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway.

The Biocon/Viatris partnership also have an insulin aspart biosimilar (Kixelle) and a trastuzumab biosimilar (Ogivri) approved in Europe [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of four bevacizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 14]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-four-bevacizumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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 May 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Mylan-s-bevacizumab-biosimilar

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Source: Biocon