Fujifilm Kyowa Kirin Biologics Co., Ltd. (“Fujifilm”) recently announced that it will partner with Mylan N.V. (“Mylan”) to commercialize a biosimilar to adalimumab developed by Fujifilm. Under the terms of the agreement, Fujifilm grants Mylan an exclusive license to commercialize the biosimilar in Europe, and will receive an up-front fee in return. In addition, Fujifilm is eligible to receive commercialization milestone payments and sales royalties. Mylan is responsible for all sales activity of the product in Europe. The parties are continuing to negotiate commercialization rights in other territories.
As we previously reported, Fujifilm’s medical marketing application for its adalimumab biosimilar was accepted for review by the European Medical Agency on May 18, 2017. A decision from the EMA is expected in the second half of 2018.