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# Opinion Urges FDA to Eliminate Unnecessary Biosimilar Clinical Trials
- URL: https://www.fdaweb.com/opinion-urges-fda-to-eliminate-unnecessary-biosimilar-clinical-trials/
- Published: 2026-10-16T15:43:03.000Z
- Updated: 2026-10-16T15:43:03.000Z
- Author: David McFarland
- Tags: Biologics

FDA should eliminate “redundant biosimilar trials when rigorous scientific evidence already establishes similarity,” a 10/16 *Newsweek* opinion piece by **Sarfaraz K. Niazi** says.

The [commentary](https://www.newsweek.com/the-fda-must-end-unnecessary-drug-trials-opinion-12577778?ref=fdaweb.com) argues that advances in analytical testing now allow manufacturers to demonstrate that proposed biosimilars are highly similar to reference biologics without necessarily conducting additional comparative clinical efficacy trials that provide little new scientific information.

The author points to recent FDA proposals to streamline biosimilar development, including reductions in certain testing requirements that could save approximately $20 million in study costs. However, Niazi contends that additional regulatory reforms are needed to remove unnecessary barriers to market entry.

“The FDA, the European Medicines Agency, and other regulatory authorities must now act,” he writes. “They should harmonize evidence-based guidelines that remove routine animal toxicity and comparative human efficacy studies when scientifically justified, while preserving rigorous analytical, pharmacokinetic, immunogenicity, and other necessary safety assessments. They should also publish clear criteria for when additional studies genuinely change a decision.

“Manufacturers, meanwhile, must invest in advanced analytical methods and transparent evidence, not simply demand easier approvals,” he concludes. “Patient groups and lawmakers should press regulators to measure success by safety, access, development time, and competition, not by the number of tests completed.”