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EU approval for Mylan and Fujifilm's Humira biosimilar

Published on 21/09/18 at 10:34am

The European Commission has approved its fifth biosimilar of the world’s best-selling drug, Abbvie’s Humira (adalimumab), granting marketing authorisation to Mylan and Fujifilm Kyowa Kirin Biologics’ (FFKB) Hulio.

The decision extends across the EU member states and the European Economic Area to all the same indications as its reference product, including rheumatoid arthritis, ulcerative colitis, psoriasis and Crohn’s disease. It follows a positive opinion for the treatment from the Committee for Medicinal Products for Human Use (CHMP) which concluded that Hulio proved adequate biosimilarity to Humira.

Come 16 October, Mylan plans to launch the therapy across European markets, while FKKB holds a nonexclusive royalty bearing license with AbbVie for the sale of Hulio in European countries.

“We're very pleased with the decision of the European Commission to grant marketing authorisation for Hulio,” Mylan President Rajiv Malik commented. “This is the fourth product that Mylan will be bringing to market in the area of complex generics and biosimilars, and we're proud to be a leader in the market formation. We've made great progress with Fujifilm Kyowa Kirin Biologics and look forward to continuing this important collaboration.”

Dr Yoshifumi Torii, FKKB President and CEO, added: “We are delighted that Hulio has received approval from the European Commission. The EC's approval of Hulio marks a significant milestone. In cooperating with Mylan, we continue to commit all efforts to bring high quality and affordable biosimilars to patients throughout European countries.”

Matt Fellows

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