Issue Date: May 16, 2011
FDA Seeks Input On Fees For Biosimilars
FDA has proposed a user fee program to pay for the agency’s review of the safety and efficacy of biosimilars, essentially generic versions of biological drugs. Under the proposal, drug manufacturers would pay about the same in user fees to obtain approval for a biosimilar product as they would for an original biological drug. FDA is also proposing to collect some fees during the development of biosimilars, not just when a company files an application for approval. “Given that the approval pathway for biosimilar and interchangeable biological products is new, FDA services are most critical for continued and successful development of biosimilar and interchangeable biological products during the investigational stage prior to submission of a marketing application,” FDA stated in a May 10 Federal Register notice. FDA is required to develop recommendations for a biosimilars user fee program for fiscal years 2013–17 under the Biologics Price Competition & Innovation Act of 2009, a provision of the omnibus health care bill. The act creates an abbreviated pathway for the approval of biosimilars. FDA is requesting input on its proposed user fee program until June 9.
- Chemical & Engineering News
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