South Korea-based Samsung Bioepis announced on 6 January 2019 that it was expanding into mainland China through a licensing agreement with China-based 3SBio. The agreement covers multiple copy biological candidates from Samsung Bioepis, including SB8, a candidate bevacizumab copy biological.

Under the terms of the agreement, Samsung Bioepis and 3SBio will collaborate across a number of areas, including clinical development, regulatory registration and commercialization in China. Samsung Bioepis will receive upfront and milestone payments, as well as royalties on sales.

And on 11 February 2019, Samsung Bioepis announced that it had made a licensing agreement with C-Bridge Capital to develop and commercialize next-generation copy biologicals in China. The agreement covers multiple candidates, including SB11, a candidate ranibizumab copy biological, and SB12, a candidate eculizumab copy biological.

China-based C-Bridge Capital has created a new biopharmaceutical company, AffaMed Therapeutics, which will collaborate with Samsung Bioepis to accelerate clinical development and registration of the next-generation copy biologicals from Samsung Bioepis in China.

Samsung Bioepis already has four biosimilars approved and marketed in Europe. These include three anti-tumour necrosis factor (TNF) biosimilars Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab), as well as an oncologic biosimilar, Ontruzant (trastuzumab) [1]. In the US, the company has one biosimilar approved and marketed, Renflexis (infliximab-abda) [2], with both SB5 (adalimumab) and SB3 (trastuzumab) biosimilar candidates currently under regulatory review.

Related article
Biosimilars of eculizumab

Biosimilars of ranibizumab

Biosimilars of bevacizumab

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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