Fujifilm Kyowa Kirin Biologics Partners with Mylan to Commercialize Biosimilar to Humira in Europe

Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced the company will partner with Mylan N.V. (NASDAQ:MYL) to commercialize FKB327, a biosimilar to Humira (adalimumab) developed by Fujifilm Kyowa Kirin Biologics. It has entered into an agreement with Mylan to grant an exclusive commercialization right of FKB327 in Europe.

“I am delighted that we entered into partnership with Mylan for an adalimumab biosimilar, FKB327 in Europe," said Dr. Yoshifumi Torii, President and CEO of Fujifilm Kyowa Kirin Biologics. “I believe that the establishment of this agreement with Mylan attests to the value of Fujifilm Kyowa Kirin Biologics' proprietary technology in biosimilars space and Mylan’s significant experience and expertise in regulatory commercialization with Fujifilm Kyowa Kirin Biologics’ scientific expertise will ensure patients across Europe benefit from the treatment option.”

Two Humira biosimilars (Amgevita , Solymbic) were approved in Europe last year. The FDA also approved two biosimilars to Humira, though marketing of the products will likely be delayed for several years due to patent litigation. Humira is the world’s best-selling biologic medication and had brand sales of approximately $4.1 billion in Europe for the 12 months ending Dec. 31, 2017, according to IQVIA.