On 24 August 2020, China-based pharmaceutical companies Bio-Thera Solutions (Bio-Thera) and BeiGene announced that they have entered into a license, distribution and supply agreement for BAT1706, an investigational copy biological to Avastin® (bevacizumab), in China.
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.
Bevacizumab BAT1706 is approved in China as a treatment for advanced, metastatic, or relapsed non-small cell lung cancer and metastatic colorectal cancer. The China National Medical Products Administration accepted Bio-Thera’s Biologics License Application for BAT1706 in June 2020. This follows its approval of Byvasda (IBI-305), a bevacizumab copy biological manufactured by Innovent Biologics, also in June .
Under the terms of the agreement, Bio-Thera has granted BeiGene the right to develop, manufacture and commercialize BAT1706 in China, including Hong Kong, Macau and Taiwan. Bio-Thera will in return receive an upfront payment; and will be eligible to receive milestone payments up to a total of US$165 million as well as tiered double-digit royalties on future net product sales. Bio-Thera will retain rights outside of the partnered territories and plans to file for marketing approval of BAT1706 in the European Union and the US in the fourth quarter of 2020. The agreement is subject to approval by Bio-Thera’s shareholders at a meeting in September 2020.
‘We are focused on bringing impactful and affordable medicines to people around the world. BAT1706, a potential biosimilar for Avastin® (bevacizumab), could become an important treatment option for solid tumour indications in China such as colorectal, lung and liver cancers. It brings us the opportunity to broaden our portfolio of commercial and registration-stage products in China and is complementary to our in-licensed and internally discovered medicines, such as tislelizumab, our marketed anti-PD-1 antibody that has also been filed in China for lung and liver cancer indications’, said Xiaobin Wu, PhD, General Manager of China and President of BeiGene.
Dr Shengfeng Li, CEO of Bio-Thera said: ‘We are delighted to enter a collaboration with BeiGene, a company with significant expertise and a robust pipeline in oncology, as it will enable us to deliver BAT1706 to more patients as soon as possible. This collaboration allows Bio-Thera to leverage BeiGene’s experience and expertise to accelerate the development and commercialization of BAT1706 as a single agent regimen or as a component of combinational therapies, and to help increase patient access to this important cancer therapeutic at affordable prices’. This is Bio-Thera’s second recent partnership; in July 2020, it announced that it had entered into a licensing agreement with Russia-based Pharmapark for its proposed golimumab biosimilar BAT2506 .
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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1. GaBI Online - Generics and Biosimilars Initiative. China approves bevacizumab copy biological Byvasda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Biosimilars/News/China-approves-bevacizumab-copy-biological-Byvasda
2. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera partners with Pharmapark to market golimumab biosimilar in Russia and other CIS countries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Pharma-News/Bio-Thera-partners-with-Pharmapark-to-market-golimumab-biosimilar-in-Russia-and-other-CIS-countries
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