Ability to design a statistical analysis plan is hampered by lack of control over, and even knowledge of, changes in the reference product's quality attributes over time, biosimilar industry says in comments on US FDA's draft guidance on statistical approaches to analytical similarity; companies seek more flexibility on statistical testing methods and on source and number of products lots for analytical comparisons.
The US FDA's draft guidance on statistical approaches for analytical similarity testing does not take sufficient account of biosimilar sponsors' lack of control over the reference product and runs the risk of overstating the role that statistics should play in establishing biosimilarity, industry representatives say.
In comments on the guidance, industry groups and individual companies also seek more flexibility from FDA on the statistical testing...
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.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
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.
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.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
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.
