Inflectra Gets Positive Opinion From CHMP For Arthritis, IBD And Plaque Psoriasis
Thursday, July 11, 2013 - 17:40
in Health & Medicine
Hospira received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending European Commission approval of Inflectra (infliximab) for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.Inflectra (infliximab) is a biosimilar medicine to the reference medicinal product, Remicade (infliximab), and is the first monoclonal antibody therapy to reach a positive opinion following review via the EMA biosimilars regulatory pathway. A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic, with comparable quality, efficacy and safety to the reference product.[1] read more