EMA accepts application for bevacizumab biosimilar BAT1706

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EMA accepts application for bevacizumab biosimilar BAT1706

Biosimilares/Novedades | Posted 04/12/2020 0 Post your comment

China-based Bio-Thera Pharmaceuticals (Bio-Thera) announced on 25 November 2020 that it had submitted an application for its proposed bevacizumab biosimilar, BAT1706, to the European Medicines Agency (EMA).

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 announcement follows positive results that were reported by Bio-Thera from a phase III trial of BAT1706 back in February 2020. The company reported that the phase III clinical trial comparing the safety and efficacy of BAT1706 versus the originator biological Avastin (bevacizumab) had met its primary endpoint and that ‘the trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with non-squamous non-small cell lung cancer’ [1].

An application for BAT1706 for the treatment of metastatic carcinoma of the colon or rectum and non-small cell lung cancer is also currently under review by China’s National Medicinal Product Administration.

The company also said that it intends to submit an application for BAT1706 to the US Food and Drug Administration ‘before the end of 2020’.

BAT1706 is Bio-Thera’s second such product. The company also gained approval in China for a copy biological, Qletli (格乐立) (adalimumab) in December 2019 [2].

The company is also developing several other proposed copy biologicals, including golimumab [1], ustekinumab [2], tocilizumab [1], secukinumab and mepolizumab, among others.

Bio-Thera partners with Pharmapark to market golimumab biosimilar in Russia and other CIS countries

LATIN AMERICAN FORUM We are pleased to announce, that starting January 2021, the launch of a new section on GaBI Online, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

References
1. GaBI Online - Generics and Biosimilars Initiative. Positive results for Bio-Thera’s arthritis copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Bio-Thera-s-arthritis-copy-biologicals
2. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/News/Bio-Thera-gains-Chinese-approval-for-adalimumab-copy-biological-and-starts-ustekinumab-trial

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Source: Bio-Thera