FDA approves Amneal’s bevacizumab biosimilar

Biosimilars/News | Posted 06/05/2022 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ (Amneal) bevacizumab biosimilar, Alymsys, the third bevacizumab biosimilar to be approved in the US.

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Bevacizumab, sold under the brand name Avastin by originator firm Genentech/Roche, is a monoclonal antibody treatment for several types of cancer including colon, lung, and renal cancer.

FDA has recently approved a new bevacizumab biosimilar: Alymsys (bevacizumab-maly) injection, which is sold by Amneal. Alymsys was developed by global biotech firm mAbxience, a subsidiary of Spanish healthcare firm Insud Pharma, while Amneal has exclusive commercialization rights in the US [1].

Alymsys was approved by the Agency in April 2022 in two doses: 100 mg/4 mL and 400 mg/16 mL. It is approved for the treatment of various cancer types including metastatic colorectal cancer in combination with chemotherapy; first-line non-squamous non-small cell lung cancer in combination with chemotherapy; recurrent glioblastoma; persistent, recurrent, or metastatic cervical cancer in combination with chemotherapy; and epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with chemotherapy. It is not approved for adjuvant treatment of colon cancer.

Chirag Patel and Chintu Patel, Co-CEOs of Amneal, said: ‘With the US approval of our second biosimilar, ALYMSYS®, we are continuing our momentum and establishing our presence in the $28 billion US biosimilars market. By combining partner assets with our own key capabilities, we are on a clear path to becoming a meaningful player in this high growth category’.

Emmanuelle Lepine, CEO of mAbxience, added: ‘Through our strategic partnership with a market leader like Amneal, we are excited to see this important product enter the US biosimilar market. For us, this is a great example of our globalization strategy materializing and how innovation and cutting-edge R & D technology can be applied to create high quality, affordable medicines that improve access to critical treatments’.

This is the second of Amneal’s products to be approved by FDA. In February 2022, the Agency also approved Amneal’s filgrastim biosimilar, Releuko (filgrastim-ayow), developed in collaboration with Kashiv Biosciences [2]. Releuko can be used for the treatment of low neutrophil count, as occurs following chemotherapy, and is the third filgrastim biosimilar to be approved by FDA. Amneal is also developing a pegfilgrastim (Neulasta) biosimilar, which is currently under review by FDA.

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1. GaBI Online - Generics and Biosimilars Initiative. Amneal and mAbxience make deal for bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 6]. Available from: www.gabionline.net/pharma-news/Amneal-and-mAbxience-make-deal-for-bevacizumab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves Kashiv Biosciences’ filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 6]. Available from: www.gabionline.net/biosimilars/news/fda-approves-kashiv-biosciences-filgrastim-biosimilar

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Source: Amneal Pharmaceuticals; US FDA

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