Global pharmaceutical company Mylan has announced it is partnering with Fujifilm Kyowa Kirin Biologics Co., Ltd. to commercialise 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 commercialise 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.
The European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application for its proposed biosimilar to Humira.
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 commercialisation 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 commercialising the product in additional territories. In addition, Mylan’s partner Biocon will receive economic benefit through this collaboration.
Mylan CEO Heather Bresch, “Our partnership with Fujifilm Kyowa Kirin Biologics for an adalimumab biosimilar in Europe is an exciting advancement for Mylan and for patients who need access to a high-quality, more affordable treatment option.”