FDA accepts application for Mylan’s bevacizumab biosimilar

Biosimilars/News | Posted 06/03/2020 post-comment0 Post your comment

US-based drugmaker Mylan announced on 27 February 2020 that the US Food and Drug Administration (FDA) had accepted its application for its bevacizumab biosimilar (MYL 1402O).

Checklist V14A17

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.

Mylan made the announcement that its candidate bevacizumab biosimilar is now under review during a quarterly earnings call. The company added that it has a user fee goal date of 27 December 2020.

Mylan is not the only biosimilars maker to report the filing of an abbreviated biologics license application (aBLA) for a bevacizumab biosimilar recently. Samsung Bioepis announced in November 2019 that FDA had accepted an aBLA for its bevacizumab biosimilar (SB8).

FDA has also already approved two bevacizumab biosimilars; Amgen’s Mvasi (bevacizumab-awwb) and Pfizer’s Zirabev (bevacizumab-bvzr) [1], both of which were launched in the US in 2019 [2].

Mylan also mentioned in its quarterly earnings call that it was ‘on track’ for its US submission in the second quarter of 2020 for its insulin aspart biosimilar.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Pfizer launching biosimilars in US and Japan but not in EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 6]. Available from: www.gabionline.net/Biosimilars/News/Pfizer-launching-biosimilars-in-US-and-Japan-but-not-in-EU

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Source: Mylan

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