Mylan and Fujifilm Kyowa Kirin Biologics announced that the European Commission has granted marketing authorization for Hulio, a biosimilar to AbbVie's Humira (adalimumab), for all indications.
This is the fifth biosimilar to the top-selling Humira approved by the European Commission. Boehringer Ingelheim and Novartis' Sandoz also have EU-approved biosimilars -- neither of which have been launched yet.
The EC approval of Hulio applies to all 28 EU member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Mylan plans to launch Hulio across various markets in Europe on or after Oct. 16.
Read the press release