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US FDA's Biosimilar Advisory Committee Policy Evolves

 
• By Derrick Gingery

If first-in-class biosimilar doesn't raise new scientific issues, it may not need advisory committee meeting, FDA's Christl says in interview with the Pink Sheet, suggesting a case-by-case approach going forward.

Identical twins

As the number of biosimilars approved by the US FDA ticks steadily upward, applications in new product classes may not need advisory committee reviews if the relevant issues already have been discussed in a prior public forum. However, that doesn't necessarily mean sponsors are completely in the clear even once a biosimilar is approved in any given class. A biosimilar seeking to enter an already populated market with data different from its competitors still may require input from the agency's outside counselors.

FDA never formally committed to holding advisory committee meetings for all new biosimilar product classes, but had been following that...

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• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

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• By Eliza Slawther

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• By Sarah Karlin-Smith and Derrick Gingery

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• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

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US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.