Fujifilm Kyowa Kirin Biologics announced the company will partner with Mylan 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.
Humira is a TNF-α1 inhibitor aimed at treating multiple chronic inflammatory conditions. The product is indicated in Europe for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. 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.
“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.”
Under the terms of the agreement between two companies, Fujifilm Kyowa Kirin Biologics grants Mylan an exclusive license to commercialize FKB327 in Europe and will receive an up-front fee. In addition, Fujifilm Kyowa Kirin Biologics is eligible to receive a subsequent commercialization milestone payment and sales royalties. Mylan will be responsible for the sales activity of the product in European countries.
The two companies continue to negotiate for commercializing the product in additional territories.
The European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for its proposed biosimilar to Humira on May 18, 2017. The companies expect to receive a decision from EMA in the second half of 2018.