European Commission Grants Marketing Authorization to Hulio, a Humira Biosimilar, for IBD, Others

European Commission Grants Marketing Authorization to Hulio, a Humira Biosimilar, for IBD, Others
The European commission (EC) has granted marketing authorization to Mylan and Fujifilm Kyowa Kirin Biologics for Hulio, a biosimilar to AbbVie's Humira (adalimumab). The marketing authorization covers all indications for which Humira is approved, including inflammatory bowel disease (IBD). The authorization comes on the heels of a positive opinion adopted by the Committee for Medicinal Products for Human Use that concluded there was sufficient data from the development program, including analytical, functional, clinical and immunogenicity (immune system reactions) data, to demonstrate Hulio’s biosimilarity to Humira. A biosimilar is a therapeutic that has similar active properties to an original product — in this case, Humira — but manufactured by a different company. Biosimilars can be approved and manufactured after the original company’s patent expires. Hulio’s approval by the EC will be applicable across all 28 European Union member countries as well as Norway, Iceland, and Liechtenstein. Following this decision, Mylan is set to launch Hulio across different countries in Europe either on or after Oct. 16. "We're very pleased with the decision of the European Commission to grant marketing authorization for Hulio. This is the fo
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