Biosimilar Interchangeability: Stakeholders Want More FDA Guidance, Fewer Hurdles
The limited discussion of interchangeability in FDA’s initial biosimilar draft guidances has left some stakeholders clamoring for more details. Others say the agency’s demand for a “higher standard” of evidence to show interchangeability is misplaced and will inhibit use of the 351(k) pathway.
You may also be interested in...
Biosimilar Guidances: Broader Populations Permitted; More Immunogenicity Requested
New draft Q&A and three final guidances from FDA offer pros and cons for sponsors of biosimilar applications.
FDA Wants Biosimilar Naming Guidance Released Before Approving An Application
The agency’s policy, planning and legislation chief says FDA hopes a draft guidance is released before the first application is reviewed.
Biosimilars: Does Low BsUFA Fee Revenue Suggest Sponsor Interest Has Stalled?
Halfway through the first year of the biosimilar user fee program, fee payments have not lived up to the expectation in President Obama’s FY 2013 budget request. Initial meetings continue to grow but at a slow pace, suggesting sponsors may remain hesitant about the pathway.