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FDA Proposes User Fees for Biosimilars

May 10, 2011

Media information and stories yesterday and today have addressed a proposal issued by the FDA regarding user fees for review of applications to market therapeutic biosimilars:

  • CQ HealthBeat — in today’s issue — apparently notes that if developers of biosimilars “were looking for a big price break on fees, they didn’t get it in the proposal released Monday.” [Content on CQ HealthBeat is only available to subscribers.]

The FDA has requested electronic or written comment within 30 days of publication of the above-mentioned notice in the Federal Register. Public stakeholder or industry stakeholder meetings are to be scheduled “on or before June 3, 2011.”

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