Mylan bags rights to commercialize Humira biosimilar in Europe

In another challenge to AbbVie’s (NYSE: ABBV) mega-blockbuster for the treatment of various immunological diseases, including rheumatoid arthritis, Netherlands-incorporated drugmaker Mylan (Nasdaq: MYL) today announced it is partnering with Fujifilm Kyowa Kirin Biologics to commercialize FKB327, a biosimilar to Humira (adalimumab) developed by the Japanese firm.

Through the partnership agreement, Mylan will leverage its regulatory platform to seek approval and commercialize the product in Europe, where several biosimilars to Humira have already been approved, including from Amgen and Boehringer Ingelheim.

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 around $4.1 billion in Europe for the 12 months ending December 31, 2017, according to IQVIA data quoted by Mylan.