Some biosimilar product sponsors are doing more clinical studies than FDA believes necessary to support licensure.
"We are seeing biosimilar sponsors proposing to do multiple studies in multiple indications, which to us is not the right...
Biosimilar Sponsors May Be Going Overboard On Clinical Data, FDA Says
Listen to this article
Studying multiple indications 'not the right way to approach biosimilars,' agency says; Amgen conducted more studies than needed for its proposed Humira biosimilar to enhance patient and physician confidence.
Learn what's happening at the US FDA. On the go.
More from US FDA Performance Tracker
- • By
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.
- • By
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.
More from Regulatory Trackers
- • By
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.
- • By
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
