According to the EC’s decision, Hulio will be available in the 28 EU member countries and three European Economic Area member states — Norway, Iceland, and Liechtenstein — on or after Oct. 16.
A biosimilar is a biologic medication with a high degree of similarity to another already approved biologic drug in terms of quality, safety, and effectiveness.
This decision is based on the positive opinion and recommendation provided by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
CHMP’s recommendation was based on postive results from the ARABESC Phase 3 clinical trial (NCT02260791). The trial compared the efficacy and safety of Hulio to that of Humira to treat rheumatoid arthritis patients for whom methotrexate, a highly used rheumatoid arthritis treatment, did not prove beneficial.
In addition to being chemically similar to Humira, this study confirmed the therapy’s safety profile, effectiveness, and immune response.
“We’re very pleased with the decision of the European Commission to grant marketing authorization for Hulio,” Rajiv Malik, president of Mylan N.V., said in a press release.
“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,” added Yoshifumi Torii, PhD, president and CEO of Fujifilm Kyowa Kirin Biologics.
In addition to ankylosing spondylitis, the committee also recommended approval of Hulio for several pediatric inflammatory diseases, including Crohn’s disease and plaque psoriasis.
Fujifilm Kyowa Kirin Biologics granted an exclusive license to Mylan for commercializing Hulio in Europe.