Bevacizumab biosimilars launched in Spain and Korea

Biosimilares/Novedades | Posted 17/09/2021 post-comment0 Post your comment

New bevacizumab biosimilars have been launched in Spain and South Korea.

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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.

India-based generics manufacturer Cipla announced on 6 September 2021 the launch of its bevacizumab biosimilar, Alymsys (BEVZ92-MB02), in Spain in association with its partner mAbxience. Almysys gained European Commission (EC) approval for commercialization in Europe in March 2021 [1]. Cipla will be in charge of marketing Alymsys in Spain. BEVZ92-MB02 was initially developed by mAbxience and first launched in Latin America (Argentina) in 2016 as Bevax [2].

Nishant Saxena, Managing Director of International Business (Europe and Emerging Markets) at Cipla, said that the partnership reinforces the company’s ‘strong commitment to continue to strengthen our biosimilars franchise and represents our unwavering determination to expand patient access to innovative therapeutic options’.

On 1 September 2021, South Korea-based Boryung Pharmaceutical (Boryung) and Samsung Bioepis announced the launch of their bevacizumab biosimilar Onbevzi in Korea. The launch comes after Boryung acquired exclusive sales rights in Korea for Onbevzi from Samsung Bioepis in May 2021. Onbevzi was approved by Korea’s Ministry of Food and Drug Safety (MFDS) in March 2021 as the first bevacizumab biosimilar in Korea [3].

Onbevzi will be sold in Korea 37% cheaper than the originator biological, Avastin. This, according to Boryung, will enable ‘more patients to receive treatment opportunities’. In addition, the company points out that Onbevzi ‘has a longer shelf life of 36 months compared to the 24 months for Avastin’.

Onbevzi has been approved by the MFDS for indications including metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, and cervical cancer.

Korea’s bevacizumab market is estimated to be worth 120 billion won annually.

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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approval for bevacizumab biosimilar Alymsys/Oyavas [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 17]. Available from: www.gabionline.net/biosimilars/news/EC-approval-for-bevacizumab-biosimilar-Alymsys-Oyavas 
2. GaBI Online - Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 17]. Available from: www.gabionline.net/biosimilars/general/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America 
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 17]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-South-Korea

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