Time and again, FDA officials had to explain the importance of the analytical characterization data in the biosimilar development paradigm.
An FDA advisory committee's overwhelming endorsement of Amgen Inc.'s ABP 501 as a biosimilar to AbbVie Inc.'s TNF-inhibitor Humira (adalimumab) belied the struggle that many of the agency's external experts faced in understanding the basic concepts underlying the 351(k) regulatory pathway.
At its July 12 meeting, the Arthritis Advisory Committee voted 26-0 that the totality of evidence supports licensure of ABP...
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.
