Policy & Regulation
Samsung Bioepis Co signs new commercialisation agreement with Biogen
8 November 2019 -

It was reported yesterday that Samsung Bioepis Co Ltd, a biopharmaceutical company, has signed a new commercialisation agreement with United States-based Biogen (Nasdaq: BIIB).

The contract has been signed for two biosimilar candidates under development by Samsung Bioepis, SB11 (ranibizumab) and SB15 (aflibercept), in the United States, Canada, Europe, Japan, and Australia.

SB11 is a biosimilar candidate referencing LUCENTIS (ranibizumab) and is currently undergoing a phase three clinical trial, while SB15 is a biosimilar candidate referencing EYLEAiii (aflibercept) and is in pre-clinical development.

The contract also offers Biogen an option to extend the commercialisation term for Samsung Bioepis' three anti-TNF biosimilars, BENEPALI (etanercept), FLIXABI (infliximab), and IMRALDI (adalimumab) in Europe for an additional five years beyond its original ten-year contract. It also offers Biogen an option to receive commercialisation rights to BENEPALI, FLIXABI and IMRALDI in China in exchange for royalties on sales in the market.