China approves bevacizumab copy biological Byvasda

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China approves bevacizumab copy biological Byvasda

Biosimilares/Novedades | Posted 26/06/2020 0 Post your comment

China-based drugmaker Innovent Biologics (Innovent) announced on 19 June 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved Byvasda (IBI-305), a bevacizumab copy biological.

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 cancers. The originator product, Avastin, is sold by Roche/Genentech.

Innovent’s product, which was independently developed by Innovent, is a copy biological of Roche’s Avastin (bevacizumab); and was submitted to the NMPA for approval back in January 2019 [1].

Byvasda has been approved by the NMPA for the treatment of patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China.

According to the Cancer Today report from the WHO’s International Agency for Cancer Research, there were 4.285 million newly diagnosed cancer patients and 2.865 million deaths from cancer in China in 2018. Among the malignant tumours in China, lung cancer ranks first both in incidence rate (0.774 million newly diagnosed patients) and mortality rate (0.691 million deaths). Colorectal cancer ranks second in incidence rate (0.517 million newly diagnosed patients) and fifth in mortality rate (0.245 million deaths).

Byvasda is Innovent’s second monoclonal antibody drug approved by the NMPA. The company also received approval for Tyvyt (sintilimab), for the treatment of patients with Hodgkin’s lymphoma in December 2018.

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that copy biologicals approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Monoclonal antibody copy biologicals accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 26]. Available from: www.gabionline.net/Biosimilars/News/Monoclonal-antibody-copy-biologicals-accepted-for-review-in-China

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Source: Innovent