Mylan To Launch Biosimilar To Humira In Europe - Quick Facts

(RTTNews) - Mylan N.V. (MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. announced the European Commission has granted marketing authorization for Hulio, a biosimilar to AbbVie's Humira (adalimumab), for all indications. The authorization follows the adoption of a positive opinion by the CHMP.

Mylan plans to launch Hulio across various markets in Europe on or after Oct. 16. Mylan and Fujifilm Kyowa Kirin Biologics partnered earlier in the current year. Fujifilm Kyowa Kirin Biologics has a nonexclusive royalty bearing license with AbbVie (Mylan has a sublicense) for the use and sale of Hulio in European countries.