Mylan, Fujifilm Kyowa Kiring Get Positive CHMP Opinion For Hulio - Quick Facts

(RTTNews) - Mylan N.V. (MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion for the marketing authorization application of Hulio, the companies' biosimilar to Humira, or adalimumab, for all indications.

The European Commission or EC's decision on the approval is expected in October 2018, which would grant marketing authorization in the 28 European Union or EU member countries and European Economic Area or EEA member states of Norway, Iceland and Liechtenstein.

CHMP also recommended approval of Hulio for the treatment of pediatric inflammatory diseases, including polyarticular juvenile idiopathic arthritis (age 2 and older), enthesitis-related arthritis (age 6 and older), plaque psoriasis (age 4 and older), Crohn's disease (age 6 and older), hidradenitis suppurativa (age 12 and older) and uveitis (age 2 and older).

Mylan CEO Heather Bresch said, "We see an urgent need to bring greater access to a more affordable treatment option for patients living with chronic inflammatory conditions such as rheumatoid arthritis, plaque psoriasis and Crohn's disease."

Fujifilm Kyowa Kirin Biologics granted an exclusive license to Mylan for commercializing biosimilar adalimumab in Europe.