Therapy Areas: Autoimmune
Mylan acquires exclusive license to commercialise biosimilar to Humira
13 April 2018 -

United States-based Mylan has acquired an exclusive license to commercialise a biosimilar to Humira (adalimumab), developed by Fujifilm Kyowa Kirin Biologics, in Europe, it was reported yesterday.

The collaboration allows Mylan to leverage its regulatory platform to seek approval and commercialise the product in Europe. According to the terms of the contract between both firms, Fujifilm Kyowa Kirin Biologics grants Mylan an exclusive license to commercialise 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 product is a TNF-inhibitor intended for treating multiple chronic inflammatory conditions. It 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.

According to IQVIA, Humira is the world's best-selling biologic medication with brand sales of approximately USD4.1 billion in Europe for the 12 months ending Dec. 31, 2017.