The European Commission (EC) granted marketing authorization for the bevacizumab biosimilar Alymsys/Oyavas (MB02), on 31 March 2021. The biosimilar is developed by mAbxience, a biopharmaceutical firm with offices in Spain, Argentina and Switzerland.
After receiving marketing authorization from the EC, mAbxience’s bevacizumab biosimilar has launched in Germany and The Netherlands, where it is marketed by STADA, with other countries soon to follow.
Bevacizumab is a humanized monoclonal antibody treatment for a number of cancers, as well as age-related macular degeneration. 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 cancers. The originator product, Avastin, is sold by Roche/Genentech.
The approval of mAbxience’s biosimilar by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation at its meetings held 25–29 January 2021 [1]. MB02 received 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.
Now that the biosimilar has received marketing authorization from the EC, it can be commercialized (under the trade names Alymsys® and Oyavas®) and sold by German pharmaceutical giant STADA. Under the terms of the agreement between mAbxience and STADA, STADA holds the marketing authorization and sales and marketing rights in 40 European countries, including all members of the EU-27.
Emmanuelle Lepine, General Manager at mAbxience, commented: ‘The launch of our Bevacizumab under the trademarks Alymsys® and Oyavas® in the European market will be a perfect example of how innovation and cutting-edge R & D technology can be applied to obtain a high quality, affordable medicine which, as well as providing alternatives for the healthcare system, will also improve patient access to costly treatments’.
STADA has already launched the product on the market in Germany and The Netherlands. They say the product will launch in other European countries soon, depending on national pricing and reimbursement clearance. CEO of STADA, Peter Goldschmidt, said: ‘Introducing the new biosimilar is testament to STADA’s strategy of being a go-to-partner for enabling patient access to biosimilars in Europe’.
EMA also recently recommended the approval of two bevacizumab biosimilars, Abevmy and Lextemy, produced by Mylan (now Viatris) [1], bringing the total number of bevacizumab biosimilars to be approved in Europe to 73 [2]. EMA recommended approval of Samsung Bioepis bevacizumab biosimilar, Onbevzi, in November 2020 [3].
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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 Apr 23]. 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 Apr 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of bevacizumab biosimilar Onbevzi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-bevacizumab-biosimilar-Onbevzi
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