Bevacizumab biosimilar approvals and launch in Japan and USA

Biosimilares/Novedades | Posted 21/10/2022 post-comment

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On 27 and 28 September 2022, Celltrion announced that its oncology biosimilar bevacizumab, Vegzelma, has been approved in Japan and the US. In October 2022, Amneal Pharmaceuticals, also announced the launch of Alymsys (bevacizumab-maly) in the US.

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 originator product, Avastin, is sold by Roche/Genentech [1].

Celltrion’s Vegzelma
Vegzelma, developed by South Korean firm Celltrion, has been approved in Japan for various cancers including metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer and glioblastoma.

Specifically in the US, Vegzelma (bevacizumab-adcd) has been approved for treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

US Food and Drug Administration (FDA) approval of Vegzelmawas based on the totality of evidence, including the pivotal phase III trial in patients with metastatic or recurrent nsNSCLC. Results showed that as a first-line treatment, Vegzelma is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.

Vegzelma is Celltrion’s third oncology biosimilar to receive approval from FDA; and has already been approved in Europe [2] and the UK in September 2022.

Amneal’s Alymsys
FDA approved the Alymsys injection in June 2022 [3]. This is sold by Amneal but was developed by global biotech firm mAbxience, a subsidiary of Spanish healthcare firm Insud Pharma, while Amneal has exclusive commercialization rights in the US [4]. The product has also been approved in Europe [5].

Alymsys was approved in the US in two doses: 100 mg/4 mL and 400 mg/16 mL. It is approved for the treatment of various cancer types (in combination with chemotherapy) including metastatic colorectal cancer; first-line nsNSCLC; recurrent glioblastoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer. It is not approved for adjuvant treatment of colon cancer [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 21]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
2. GaBI Online - Generics and Biosimilars Initiative. EC approves bevacizumab biosimilar Vegzelma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 21]. Available from: www.gabionline.net/biosimilars/news/ec-approves-bevacizumab-biosimilar-vegzelma
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves Amneal’s bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 21]. Available from: www.gabionline.net/biosimilars/news/fda-approves-amneal-s-bevacizumab-biosimilar
4. 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 Oct 21]. Available from: www.gabionline.net/pharma-news/Amneal-and-mAbxience-make-deal-for-bevacizumab-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for bevacizumab biosimilar Alymsys/Oyavas [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 21]. Available from: www.gabionline.net/biosimilars/news/EC-approval-for-bevacizumab-biosimilar-Alymsys-Oyavas

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