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Biosimilar Guidance Development Timelines Criticized By Docs And Patients

 
• By Sue Sutter

FDA's user fee deal with sponsors sets target dates for documents on interchangeability, naming and labeling, but non-industry stakeholders urge agency to accelerate their release; guidance development efforts will get boost in BsUFA II with funding for new dedicated biosimilars unit starting in fiscal year 2018.

FDA entrance sign 2016

The FDA/industry-negotiated agreement to renew the biosimilar user fee program provides too much lag time for issuing and finalizing key guidance documents, representatives from consumer and professional groups said at an Oct. 20 meeting.

However, the agreement’s target dates for a long-delayed draft guidance on interchangeability, and final guidance documents on nonproprietary naming and...

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