The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Hulio, a biosimilar to Humira, for the treatment of a number of chronic inflammatory diseases including ankylosing spondylitis.
A final decision by the European Commission is expected in October. If approved, the agency would grant marketing authorization for Hulio in all member states of the European Union and the European Economic Area.
Hulio, developed by Mylan N.V. and Fujifilm Kyowa Kirin Biologics, is a biosimilar to Humira (adalimumab). A biosimilar is a biological medicine with a high degree of similarity to another already approved biological medicine in terms of quality, safety, and efficacy.
Humira (adalimumab) is an anti-TNF drug that reduces inflammation. It targets a protein known as tumor necrosis factor (TNF), which is involved in inflammatory diseases such as rheumatoid arthritis and ankylosing spondylitis.
The CHMP’s decision follows the results of the ARABESC Phase 3 clinical trial (NCT02260791), which compared the efficacy and safety of Hulio to those of Humira in rheumatoid arthritis patients who had inadequate disease control on methotrexate, a highly used rheumatoid arthritis treatment.
The study revealed no significant differences between the two therapies in terms of safety, efficacy, and immune response.
“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. CHMP’s decision to recommend the approval of Hulio, a biosimilar to adalimumab, represents a positive step to bring this treatment to patients and demonstrates the strength of our collaboration with Fujifilm Kyowa Kirin Biologics,” Mylan CEO Heather Bresch said in a press release.
“We continue to commit all efforts to provide high quality biosimilars and strongly hope that Hulio, the first biosimilar product from Fujifilm Kyowa Kirin Biologics, will provide tremendous value for patients throughout European countries,” added Yoshifumi Torii, Fujifilm Kyowa Kirin Biologics’ president and CEO.
In addition to ankylosing spondylitis, the committee also recommended approval of Hulio for several pediatric inflammatory diseases.
Fujifilm Kyowa Kirin Biologics granted an exclusive license to Mylan for commercializing the biosimilar of adalimumab in Europe.