Mylan's Herceptin biosimilar faces questions on off-label use and manufacturing, while Amgen's Avastin biosimilar could be template for other products.
Despite a glowing endorsement for its Herceptin biosimilar, Mylan NV already is facing additional questions about the product's use with other cancer treatments and in different settings beyond its requested indications.
The Oncologic Drugs Advisory Committee voted unanimously (16-0) July 13 to recommend approval of MYL-1401O.
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.
