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China approves bevacizumab copy biological Ankada Posted 31/01/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 9 December 2019 that it had approved Ankada, 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.

Ankada (QL-1101) was developed by China-based Qilu Pharmaceutical. The copy biological has been approved for the treatment of advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer.

Qilu Pharmaceutical says that it carried out more than 100 comparative studies on its product during the development process. These comparative studies, according to the company, showed that Ankada is comparable with the originator product (Roche’s Avastin) in terms of structure, quality, activity, safety and efficacy.

The company submitted its application to the NMPA in August 2018, and in October 2018 the product was included in the priority review list as a major national speciality product.

The approval of Qilu Pharmaceutical’s Ankada is expected to reduce the burden on patients and medical insurance and increase the availability of drugs by bringing a low-cost equivalent domestic drug to Chinese patients.

Qilu Pharmaceutical is also carrying out a phase III clinical trial for a copy biological of Amgen’s Prolia/Xgeva (denosumab) [1].

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. Qilu starts phase III trial for denosumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. Available from: www.gabionline.net/Biosimilars/News/Qilu-starts-phase-III-trial-for-denosumab-copy-biological

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Source: Qilu Pharmaceutical

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