While the FDA has increased its approval rate for biosimilars in recent years, the agency still lags behind its European counterpart.
In the backdrop of the FDA’s efforts, the Trump administration is also making concerted efforts to introduce drug pricing reforms in the US.
Earlier in October 2025, the agency also debuted a prioritisation programme within the abbreviated new drug application (ANDA) framework, which will see US generic and biosimilar manufacturers who test and produce their therapies on home soil gain access to faster review times.
While the Association for Accessible Medicines’ (AAMs) senior VP of sciences and regulatory affairs, Giuseppa Randazzo, previously told Pharmaceutical Technology that he welcomed this pilot, Randazzo noted that there must be a change in market dynamics within the generics segment for the scheme to succeed.
FDA looks to match EMA biosimilar approval rates
The FDA’s most recent framework on biosimilars builds on a similar scheme debuted by the agency in October 2025, which set out to reduce reliance on “unnecessary clinical testing” such as comparative efficacy studies to expedite biosimilar development and reduce costs.
This comes as the FDA looks to close the biosimilar approval gap between itself and the European Medicines Agency (EMA), which greenlit 22 more biosimilars than the FDA in 2025. Thus far, the agency has made some progress towards this goal, as 19 biosimilars got the FDA’s regulatory go-ahead in 2024 – marking a significant increase from the five that achieved this milestone in 2023.
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