USP Defends Mandatory Drug Standards For Biosimilars As FDA Expresses Concern

June 28, 2016 at 2:39 PM
The U.S Pharmacopeial Convention defended the role of mandatory USP drug quality standards in biosimilar development as FDA and Senate lawmakers seek to remove biologics from such monographs. USP released a white paper pointing to manufacturers in Europe that utilize monograph standards in product development and cite them in their regulatory approval applications. USP argues that standards increase access to quality medicines while decreasing healthcare costs.“Relying on public standards facilitates regulatory approval and eliminates costly and time-consuming duplication of efforts...


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