The approval of Hulio is based on adoption of positive opinion by the Committee for Medicinal Products for Human Use (CHMP).
The CHMP determined that development program, including analytical, functional, clinical and immunogenicity data, showed biosimilarity with the reference product Humira.
The approval allows to market Hulio in all 28 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.
Mylan is planning to introduce Hulio in different European markets in October.
Earlier this year, Mylan and Fujifilm Kyowa Kirin Biologics have collaborated, under which Fujifilm is provided with nonexclusive royalty bearing license by AbbVie for the use and sale of Hulio in European countries. Mylan holds a sublicense, under the same deal.
Mylan president Rajiv Malik said: “We’re very pleased with the decision of the European Commission to grant marketing authorization for Hulio. 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.”
Fujifilm Kyowa Kirin Biologics president and CEO Dr Yoshifumi Torii said: “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.”
Hulio has been approved for the same indications of Humira, including rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, Ulcerative colitis, and uveitis.
Hulio can be used to treat polyarticular juvenile idiopathic arthritis in children aged 2 and older, enthesitis-related arthritis in children aged 6 and older, plaque psoriasis in children aged 4 and older, Crohn’s disease in children aged 6 and older, Hidradenitis suppurativa in children aged 12 and older and Uveitis in children aged 6 and older.
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