Non-inferiority study in advanced follicular lymphoma patients created uncertainty as to whether there were any clinically meaningful differences between CT-P10 and Genentech’s Rituxan, but a newly submitted, equivalence study appears to have put those concerns to rest for agency reviewers.
Celltrion Inc.’s resubmitted biosimilar application for CT-P10 appears to have addressed the US FDA’s first-cycle review concerns as to whether there are any clinically meaningful differences between the proposed biosimilar and its reference product, Genentech Inc.’s Rituxan (rituximab).
In briefing documents released ahead of an Oct. 10 Oncologic Drugs Advisory Committee meeting, FDA reviewers conclude the analytical data...
An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.
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.
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.
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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