FDA Proposes User Fees for Biosimilars

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:

• "FDA requests input on development of user fee program for biosimilar and interchangeable biological products" is a "note to correspondents" issued by the FDA on May 9.

• "Initial biotechnology drug copies may get brand-name fees" is a report by Catherine Larkin on Bloomberg.com, dated May 9.

• "FDA proposes fee system for new drug class" is a report by Sam Baker on The Hill's Healthwatch blog, also dated May 9.

• 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."