FDA considering public statement reflecting its view that biosimilars not deemed interchangeable will not be substituted at pharmacy, but the extent such a statement would limit payer-driven practice remains in question.
Patient advocacy groups and some of FDA's external advisors are urging the agency to come out with a public stance against non-medical switching of patients from innovative biologics to non-interchangeable biosimilars.
However, the extent of any agency statement – and its impact on payers and pharmacy benefit managers who have the...
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.
