Biosimilars & Generics

‘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 FDA proposed allowing sponsors that use domestic API suppliers and finished dosage form manufacturing and conduct BE testing in the US to receive a shorter ANDA review.

The FDA wants to waive facility fees for three years if a sponsor breaks ground on a US-based manufacturing plant, but industry is concerned the idea will force other sponsors to subsidize competition.

FDA officials want to charge the generic drug program fee per ANDA owned going forward, rather than the current practice of separating firms into different fee-paying tiers based on the number of ANDAs owned.

The latest step in the long-running saga of Hikma and Amarin’s induced infringement dispute over Vascepa is a US Supreme Court review of the litigation, which could result in changes to generic drug skinny-label policy.