Biogen announced Wednesday that it has reached an agreement with Samsung Bioepis that gives it exclusive rights to market the latter's ophthalmology biosimilar candidates, SB11 referencing Roche's Lucentis (ranibizumab) and SB15 referencing Regeneron Pharmaceuticals' Eylea (aflibercept), in major global markets, including the US, Canada, Europe, Japan and Australia. Under the terms of the proposed transaction, Biogen will make a $100-million upfront payment to Samsung Bioepis, which is also eligible for up to $210 million in additional development, regulatory and sales-based milestones.
"We are excited about the potential to bring biosimilars to a new therapeutic area as well as new regions around the world," commented Biogen CEO Michel Vounatsos, adding the transaction will "expand the potential for our leading biosimilars business worldwide, while complementing [our] presence in ophthalmology." Samsung Bioepis will be responsible for development and will supply both products to Biogen at a pre-specified gross margin.
The deal also calls for Biogen to obtain exclusive commercialisation rights for Samsung Bioepis' anti-TNF portfolio, including Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab), in China in exchange for royalties on sales there. In addition, Biogen will have the option to extend its existing commercialisation rights for Benepali, Flixabi and Imraldi in Europe by another five years for a $60-million fee. Biogen reported sales of $545.1 million from those biosimilar products in 2018, a 43% increase over the previous year.
Biogen and Samsung BioLogics established Samsung Bioepis as a biosimilars joint venture in 2012. Last year, Biogen paid $700 million to exercise its right to increase its ownership position in the joint venture to 49.9%.
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