Biosimilars

In a signal that prescription drug and generic drug user fee talks are nearing completion, the FDA and industry are preparing to start biosimilar user fee reauthorization talks with America First and other issues potentially looming.

Instead of requiring a three-way pharmacokinetic bridging study that compares the US reference product, foreign reference product and proposed biosimilar, a sponsor should justify the relevance of clinical data comparing a proposed biosimilar to a foreign product.

During a candid and revealing discussion, lobbying experts shared strategies for getting the generics and biosimilars industry’s message heard by lawmakers.

As FDA streamlines regulatory requirements for biosimilars, Robert Foster said during AAM’s annual meeting that if a company brings high-quality data to the agency, ‘sometimes the student ... teaches the tenured professor something new.’

From enforcing new GMP norms to risk-based inspections and 850 CAPA notices, India’s drugs regulator is moving to tighten compliance across domestic pharma units. A striking step up in the regulator’s internal scientific cadre and more regulatory rationalization are also on the cards.

Moves to issue a compulsory license for Lilly’s GLP-1tirzepatide products Mounjaro and Zepbound come as Brazil prepares to make its own versions of Novo Nordisk’s semaglutide and liraglutide.

‘Over the hump, and about to pick up speed’ is how Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, described the category as she sets out the agency’s plans for more biosimilar progress domestically and internationally in 2026.

The European Commission sees the value of biosimilars, but its biotech vision lacks competitive incentives to build on the region’s relevance.

The health technology assessment institute said its recommendation for the multiple sclerosis drugs, Tysabri and Tyruko, highlighted its continued efforts to drive the adoption of biosimilars across the National Health Service.

In the wake of recent FDA guidance setting out a streamlined approach to biosimilar approval, developers have spent the past month responding. While most reactions have been enthusiastic, some firms urged caution.

The European Medicines Agency has said that Anavex’s Alzheimer’s candidate should not be authorized for use in the EU due to safety and efficacy concerns. Seven other products, including two new cancer drugs, received positive opinions.

A Teva official suggested the increasing reliance on analytical characterizations rather than clinical studies to show biosimilarity should warrant user fee structure changes.

FDA’s proposed easing of biosimilar pathways is a mixed blessing for CROs even as it, along with tariff threats and funding scarcity, has led to paused clinical studies. Parexel’s India head talks about keeping up with the regulation and other AI-led changes in this interview.

After 10 years of adding suffixes to all new biologic and biosimilar nonproprietary names, FDA officials are considering whether it is still necessary for pharmacovigilance purposes.

Elevating the Office of Therapeutic Biologics and Biosimilars out of the Office of New Drugs and providing signatory authority could help speed biosimilar reviews, OTBB Director Sarah Yim said.

Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.

Pink Sheet editors discuss FDA announcements that clinical efficacy studies would no longer be required for biosimilar development, as well as the additional information from the agency on the intent of its “Simple Reform” of the inspection staff.

The guidance is part of the FDA’s effort to encourage more biosimilar development by streamlining approval requirements and lowering development costs.

The new guidance says comparative clinical trials are not a prerequisite for all biosimilars, a notable step for the FDA, but the commissioner added that biosimilar prices should be significantly lower than the reference product at launch.

FDA officials said the pilot program needs more time to determine its return on investment as user fee renewal talks near.