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 Norway, Iceland 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 tumor necrosis factor (TNF) – an inflammatory molecule that plays a significant role in several autoimmune diseases. Hulio is part of an expected wave of Humira biosimilars in Europe. CHMP’s positive opinion follows the company’s filling for a marketing authorization application of Hulio for several indications that mirror those given to Humira. In addition to Crohn's disease and ulcerative colitis, these include rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, and uveitis. Additionally, CHMP recommend that Hulio also be approved for pediatric inflammatory diseases such as polyarticular juvenile idiopathic arthritis (indicated for 2 years of age and older),
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