The National Medical Products Administration (NMPA) in China has accepted an investigational new drug (IND) application for a bevacizumab copy biological developed by 3SBio and Samsung Bioepis.
3SBio is a China-based pharmaceutical company, responsible for the etanercept copy biological Yisapiu [1]. They have formed a licensing agreement with Korea-based Samsung Bioepis, which includes the candidate bevacizumab copy biological SB8 [2].
Bevacizumab is a humanized monoclonal antibody treatment for a number of cancers, as well as age-related macular degeneration. 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.
In September 2020, 3SBio announced that the NMPA in China accepted its IND for SB8, with the indications focus on metastatic colon cancer and non-small cell lung cancer. According to the Chinese National Cancer Center, there were 376,000 new cases of colorectal cancer and 733,300 new cases of lung cancer in China in 2015.
3SBio’s subsidiary Sunshine Guojian will be responsible for clinical development and commercialization of SB8 in mainland China excluding Hong Kong, Macao and Taiwan.
SB8, which has the trade name Aybintio, was recommended for approval by the European Medicines Agency in June 2020 [3], followed by marketing authorization approval in Europe in August 2020.
Aybintio has been approved in Europe for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced/metastatic renal cell cancer, epithelial ovarian, fallopian tube and primary peritoneal cancer, and cervical cancer. In China however, indications will focus on metastatic colon cancer and non-small cell lung cancer.
Chairman of 3SBio, Dr Jing Lou, said: ‘3SBio looks forward to accelerating the clinical development of SB8 in China, and to broaden 3Bio’s product portfolio in the oncology area. SBio will continue to strengthen its leadership status in biopharmaceutical industry through internal R & D initiatives and strategic collaborations to bring more high quality and urgently needed products to market more quickly, both in China and international market’.
Samsung Bioepis recently released positive phase III trial data for Aybintio [4], demonstrating equivalent clinical efficacy and safety to reference bevacizumab, Avastin.
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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References
1. GaBI Online - Generics and Biosimilars Initiative. China approves new formulation of etanercept copy biological Yisaipu [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 16]. Available from: www.gabionline.net/Biosimilars/News/China-approves-new-formulation-of-etanercept-copy-biological-Yisaipu
2. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis makes deals for copy biologicals in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 16]. Available from: www.gabionline.net/Pharma-News/Samsung-Bioepis-makes-deals-for-copy-biologicals-in-China
3. GaBI Online - Generics and Biosimilars Initiative. EMA approves bevacizumab and teriparatide biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 16]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-bevacizumab-and-teriparatide-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Phase III trial updates of Samsung Bioepis’ bevacizumab and aflibercept biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 16]. Available from: www.gabionline.net/Biosimilars/Research/Phase-III-trial-updates-of-Samsung-Bioepis-bevacizumab-and-aflibercept-biosimilars
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