FDA says problem with protein misfolding with Sandoz' Enbrel biosimilar candidate unlikely to generate unique toxicity issues in extrapolated indications.
The path down the biosimilar approval pathway has been a bumpy one for FDA's advisory committees, with many advisors expressing discomfort with the very idea of relying on analytic similarity as the basis of approval even as FDA has worked to ensure that only the most robust applications reach the panel review stage.
But the Arthritis Advisory Committee's July 13 review of Sandoz Inc.'s GP2015, which references Amgen Inc.'s tumor necrosis...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
