Like biosimilar candidates Zarxio and Inflectra before it, Amgen's ABP 501 enters its advisory committee review with FDA's full-throated endorsement.
FDA's decision to convene an advisory committee for early biosimilar applications may be viewed as a strong predictor of approval if the experience of Amgen Inc.'s ABP 501 mirrors that of its two predecessors to reach this stage.
Agency briefing documents released ahead of the Arthritis Advisory Committee's July 12 meeting on ABP 501, a proposed biosimilar to...
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.
