Mylan and Fujifilm arm Join up on Biosimilar

Mylan has joined forces with Japan’s Fujifilm Kyowa Kirin Biologics to commercialize a biosimilar to Abbvie’s Humira (adalimumab) that has been developed by the Japanese company.

Under the terms of the agreement, Mylan will leverage its regulatory platform to seek approval and commercialize the product in Europe, for which the Japanese partner will provide an exclusive license. In addition to an up-front payment, Fujifilm Kyowa Kirin Biologics will be 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, and the  two companies will continue to seek permission to commercialize the product in additional territories. Mylan's drug partner Biocon will also receive “economic benefit” through the collaboration, the companies said.

Humira, the world's best-selling biologic medication, is a TNF-inhibitor aimed at treating multiple chronic inflammatory conditions. In Europe, it is indicated for treatment of a variety of conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.

The branded drug had sales of about $4.1 billion in Europe in 2017.

For Mylan, a Netherlands-domiciled, US-managed generics producer, expanding access to biologics through the introduction of biosimilars worldwide is a key area of focus, said CEO Heather Bresch. The partnership with Fujifilm Kyowa Kirin Biologics will support patients living with chronic autoimmune conditions, who need access to a high-quality, more affordable treatment option, she said.

The European Medicines Agency (EMA) accepted Mylan’s Marketing Authorization Application for the proposed biosimilar in May 18, 2017, and the companies expect to receive a decision in the second half of 2018.