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Samsung Bioepis signs Biogen biosimilar deal

Nov 08,2019
Samsung Bioepis signed a deal potentially worth $370 million with Cambridge, Massachusetts-based Biogen.

The agreement gives the U.S. company the right to commercialize five of the Korean company’s biosimilars in Europe and other global markets, Samsung Bioepis said Thursday.

Two of the five are biosimilar candidates currently under development: SB11 and SB15. They are biosimilars for eye diseases. SB11 references ranibizumab, sold under the name Lucentis, while SB15 references aflibercept, sold as Eylea.

SB11 is currently in Phase-3 clinical trials, while SB15 is in pre-clinical development. This deal gives Biogen commercialization rights for the two products in the United States, Canada, Europe, Japan and Australia.

The deal also extends existing commercialization contracts for three of Samsung’s Bioepis biosimilars that treat autoimmune diseases - Benepali, Flixabi and Imraldi. This adds five years to the existing contracts, which originally allowed for 10 years of commercialization. The expiration for the Benepali and Flixabi agreements was 2026. For Imraldi, it was to be 2028.

Under the agreement, Samsung Bioepis will receive upfront payments of $100 million, and up to $270 million in milestone and option payments, as well as a share of sales. For both deals, Samsung Bioepis will be responsible for development, regulatory registration and the manufacturing of the products, while Biogen will be responsible for commercialization.

Samsung Bioepis called the achievement a “testament to Samsung Bioepis’ strong track record in the field of biosimilars.”

Biogen own 50 percent minus a share of Samsung Bioepis.

“In Europe, we have been very pleased with Biogen’s commercialization efforts with our anti-TNF medicines,” said Ko Han-sung, Samsung Bioepis’ president and CEO.

BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]