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FDA Hearings Underscore Need for Clear Policy on Biosimilars

July 12 and 13 hearings of the FDA’s Arthritis Advisory Committee cleared the way for two new biosimilars, adalimumab and etanercept. The committee unanimously supported manufacturers’ applications for the drugs – but that wasn’t the only point of consensus. Participants and even committee members expressed concerns about unfinished regulatory policy and the need to prioritize patient safety.