Full Breakdown
FDA Must End Unnecessary Biosimilar Trials, Says Expert
By Drooid · · How we work
The Core Issue: Redundant Studies Blocking Access
Pharmaceutical scientist Dr. Sarfaraz K. Niazi argues that many biosimilar trials add little scientific value while inflating costs and delaying patient access to affordable biologic medicines. He contends that when rigorous analytical, pharmacokinetic and immunogenicity data already demonstrate similarity, additional comparative efficacy studies are unnecessary and ethically questionable.
Background & Context
The U.S. Food and Drug Administration (FDA) defines biosimilars as products highly similar to approved biologics with no clinically meaningful differences in safety, purity, or potency. Biologics accounted for 51 % of U.S. drug spending in 2024 despite representing only 5 % of prescriptions. In March, the FDA released draft recommendations to streamline certain pharmacokinetic (PK) testing, estimating potential study-cost savings of up to 50 % (about $20 million). This follows an October 2025 draft guidance that suggested comparative efficacy studies may be unnecessary when other evidence adequately establishes biosimilarity.
Impact of Unnecessary Trials
Niazi notes that each superfluous trial can cost tens of millions of dollars, creating financial barriers for smaller manufacturers and preserving market dominance for established brands. The resulting delays keep life-saving treatments out of reach for uninsured or underinsured patients, especially those with cancer, autoimmune disorders, or chronic diseases. He likens the situation to weighing a diamond on a bathroom scale: the second measurement adds uncertainty without improving accuracy.
Calls for Regulatory Reform
The expert urges the FDA, the European Medicines Agency, and other regulators to adopt harmonized, evidence-based guidelines that eliminate routine animal toxicity and comparative human efficacy studies when scientifically justified. He recommends publishing clear criteria for when additional studies would meaningfully affect regulatory decisions, while retaining necessary safety assessments such as PK and immunogenicity testing. Niazi also calls on patient groups and lawmakers to pressure regulators to prioritize safety, access, development time, and competition over the sheer number of completed trials.
Outlook
If regulators implement the proposed changes, increased competition from multiple biosimilar manufacturers could drive down prices and expand access to advanced biologic therapies, turning currently unaffordable treatments into routine options for a broader patient population.