Biogen expanding biosimilars portfolio with Samsung Bioepis deal

Samsung Bioepis today revealed that it has entered into a new commercialization agreement with Biogen (Nasdaq: BIIB) for two biosimilar candidates under development by Samsung Bioepis, SB11 (ranibizumab) and SB15 (aflibercept), in the USA, Canada, Europe, Japan, and Australia.

SB11, a biosimilar candidate referencing Lucentis (ranibizumab), is undergoing Phase III clinical trial, while SB15, a biosimilar candidate referencing Eylea, (aflibercept), is in pre-clinical development.

In addition, the agreement provides Biogen an option to extend the commercialization term for Samsung Bioepis’ three anti-TNF biosimilars – Benepali (etanercept), Flixabi (infliximab), and Imraldi (adalimumab) – in Europe for additional five years, extending the original 10-year agreement. Benepali is the most prescribed etanercept in France, Germany, Italy, Spain, and the UK. Imraldi is the leading adalimumab biosimilar in Europe, according to Samsung Bioepis, a joint venture between the Korean conglomerate Samsung and Biogen. The agreement also provides Biogen an option to receive commercialization rights to Benepali, Flixabi and Imraldi in China in exchange for royalties on sales in the market.