Biosimilar sponsors are 0-3 so far in attempts to win US FDA approval for copies of Amgen’s pegfilgrastim (Neulasta). FDA’s recent review of a novel clotting factor formulation offers a clue why it is turning out to be harder than it seems to copy a pegylated protein.
When the biosimilar pathway was enacted in the US, there were some shared assumptions about which products might be first to win FDA approval using the abbreviated pathway, and which might take more time.
Relatively “simple” proteins would surely be the first ones through – with filgrastim (Amgen Inc.’s Neupogen) and epoetin (Amgen’s...
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.
