CHMP Favors Approval of Hulio, Biosimilar to Humira, to Treat IBD Patients in EU

CHMP Favors Approval of Hulio, Biosimilar to Humira, to Treat IBD Patients in EU
Hulio, a biosimilar to Humira (adalimumab), has been given a favorable opinion by the Committee for Medicinal Products for Human Use (CHMP) to treat a number of inflammatory diseases in the EU — including Crohn's disease and ulcerative colitis, the product's manufacturers,  Mylan and Fujifilm Kyowa Kirin Biologics, announced in a press release. CHMP is a branch of the European Medicines Agency, the regulatory agency for medical treatments and products in the 28-member EU plus NorwayIceland and Liechtenstein. A final decision by the European Commission is expected in October. Hulio, if approved for marketing by the EC, will be available as a 40mg solution for injection, CHMP said in a report detailing its opinion. A biosimilar is a medical product that has identical properties to the original but is manufactured by a different company. Based on the original's “innovator” products, biosimilars are approved and can be produced after original company’s patent expires. Humira blocks the activity of
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