Global pharmaceutical company Mylan N.V. has announced it is partnering with Fujifilm Kyowa Kirin Biologics Co., Ltd. to commercialize a biosimilar to Humira® (adalimumab) developed by Fujifilm Kyowa Kirin Biologics. Through the partnership agreement, Mylan will leverage its regulatory platform to seek approval and commercialize the product in Europe.
Humira is a TNF-inhibitor1 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.
Mylan CEO Heather Bresch, "Expanding access to biologics through the introduction of biosimilars around the world is a key area of focus for Mylan. Our partnership with Fujifilm Kyowa Kirin Biologics for an adalimumab biosimilar in Europeis an exciting advancement for Mylan and for patients who are living with chronic autoimmune conditions and need access to a high-quality, more affordable treatment option."
President Rajiv Malik added, "We believe Mylan's strong regulatory commercial platform in Europe and scientific leadership in the biosimilars space make us an ideal partner of choice. These attributes combined with Fujifilm Kyowa Kirin Biologics' expertise in biologics, position the two companies to bring an adalimumab biosimilar to the European market in the near term."
The European Medicines Agency (EMA) accepted for review the Marketing Authorisation 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.
Under the terms of the agreement between two companies, Fujifilm Kyowa Kirin Biologics grants Mylan an exclusive license to commercialize the adalimumab biosimilar 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. In addition, Mylan's partner Biocon will receive economic benefit through this collaboration.