Mylan and Fujifilm Kyowa Kirin Biologics were granted marketing authorization for biosimilar Hulio (adalimumab) by the European Commission for all the indications of its reference product, AbbVie‘s Humira (adalimumab), including juvenile idiopathic arthritis.
The European marketing authorization is based on a positive recommendation from the Committee for Medicinal Products for Human Use, stating that Hulio has a similar chemistry, functional, immunogenic, and clinical profile as Humira.
The approval applies to all 28 European Union countries, plus Norway, Iceland, and Liechtenstein.
“We’re very pleased with the decision of the European Commission to grant marketing authorization for Hulio,” Rajiv Malik, Mylan’s president, 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,” said Yoshifumi Torii, PhD, president and CEO at Fujifilm Kyowa Kirin Biologics.
Hulio is a monoclonal antibody that binds to the inflammatory molecule tumor necrosis factor (TNF)-alpha to curb inflammation in chronic inflammatory conditions such as juvenile idiopathic arthritis.
The partnership between Mylan and Fujifilm Kyowa Kirin Biologics leverages Fujifilm’s license for the use of Hulio in Europe and Mylan’s strong regulatory platform to commercialize the product.
Biosimilars are an affordable therapeutic option with similar clinical effectiveness as currently available brand-name medications.
Different from generic medications, which are an exact copy of their reference medicine and must have the same chemical structure, biosimilars are highly similar, but not exact copies, of the products they are designed to resemble.
“Biosimilars represent a huge opportunity in Europe to drive better patient access through high quality, value medications that support healthcare systems across the region to deliver ongoing excellent care,” said Jacek Glinka, president of Mylan Europe.
In addition to juvenile arthritis, Hulio is also approved for use in other inflammatory conditions in children — namely Crohn’s disease, uveitis (inflammation of the uvea, the middle layer of the eye), plaque psoriasis — and adults, including rheumatoid arthritis, psoriasis, and ankylosing spondylitis, among others.
Hulio is expected to be available in Europe on or after Oct. 16.