The US Food and Drug Administration (FDA) has further updated its regulatory framework around biosimilar medicines in a bid to reduce drug prices on home soil.
Through the new draft guidance, the FDA will relax its regulatory framework around biosimilar development to streamline the process. This means that drugmakers can now submit clinical data comparing their biosimilar’s activity to a non-US-licensed comparator product without comparison to a US-listed product for approval, as long as the move can be “scientifically justified”.
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Through this draft guidance, the agency will also no longer require a three-pronged pharmacokinetic (PK) study that directly compares a biosimilar’s activity with both a US-licensed reference product and a non-US-licensed comparator – instead accepting just comparison with a non-US equivalent in a scientific context the FDA deems justifiable.
According to the regulator, this guidance could cut PK study costs by up to half, taking the approximate figure to run such a study down to $20m.
Currently, the agency estimates that branded biologic medicines account for 51% of drug spending across the US, while making up only 5% of prescriptions. As biosimilar drugs are generally cheaper than their branded counterparts, the FDA notes they can potentially offer more affordable and accessible treatment options for those unable to afford branded medicines out of pocket.
“Using common sense, we are embracing more precise analytical testing approaches that have been used in the past,” said the FDA’s commissioner, Marty Makary, in a 9 March statement addressing the draft guidance.
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By GlobalDataFDA 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.
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.
