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# Are Comparative Clinical Studies of Biologics Worth the Time and Cost?
- URL: https://www.fdaweb.com/are-comparative-clinical-studies-of-biologics-worth-the-time-and-cost-d5161827/
- Published: 2026-09-23T16:00:00.000Z
- Updated: 2026-09-23T16:00:00.000Z
- Author: David McFarland
- Tags: Biologics, Legacy-ID-D5161827, #Import 2026-09-24 19:50

FDA says a meta-analysis conducted by CDER scientists found that pharmacokinetic similarity studies provided useful information to descriptively evaluate the immunogenicity and safety of biologics, and that comparative clinical studies did not appear to be more definitive. In an online [post](https://www.fda.gov/drugs/regulatory-science-action/comparative-clinical-studies-assessing-safety-and-immunogenicity-biosimilars?ref=fdaweb.com), the agency says the scientists suggest that their findings be considered when determining whether the information obtained through comparative clinical studies, given their additional cost and duration, outweighs the benefits of a more abbreviated biosimilar development program.

The post says the key findings of the agency’s meta-analysis were:

- in an analysis of data submitted in support of 35 biosimilars, CDER scientists did not find statistically significant risk differences for anti-drug antibodies or neutralizing antibodies across all studied biosimilars, regardless of whether the estimates were derived from pharmacokinetic studies or comparative clinical studies; and
- the estimated risks of patients experiencing any adverse event, serious adverse events, adverse events leading to discontinuation, and death were lower in the pharmacokinetic studies compared with the comparative clinical studies, but overall differences were small and were statistically significant only for serious adverse events.

“The amount and type of clinical evidence that is necessary to establish biosimilarity, and the role of comparative clinical studies, has been an important question for regulatory authorities since the biosimilar pathway was established,” FDA concludes. “The data from this study, along with other research findings, are part of the overall scientific evidence supporting FDA’s updated recommendations for assessing the need for comparative clinical studies to support a demonstration of biosimilarity.”