Last week, Fujifilm Kyowa Kirin Biologics (FKB) and Mylan announced that they will partner with one another to commercialize in Europe FKB327, a biosimilar of adalimumab developed by FKB. As we previously reported, the European Medicines Agency (EMA) accepted FKB’s Marketing Authorization Application for review on May 18, 2017 and the companies expect to get a decision from EMA by the second half of this year. Under the agreement, FKB grants Mylan an exclusive license to commercialize the adalimumab biosimilar in Europe for an up-front fee, subsequent milestone payments and sales royalties. According to the companies’ press releases, Mylan will be responsible for the sales activity of the product in European countries, and the two companies continue to negotiate for commercializing the product in additional territories.
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