Questions about US FDA's handling of orphan indications may arise again during upcoming Oncologic Drugs Advisory Committee meeting on ABP215, a proposed Avastin biosimilar.
Amgen Inc. again may face concerns about damage to orphan drug incentives when its proposed biosimilar of Genentech Inc.'s Avastin (bevacizumab) comes before the US FDA's Oncologic Drugs Advisory Committee.
Amgen and partner Allergan PLC are seeking approval of ABP215 for six of Avastin's indications. (See box.) But two...
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.
