Numerous patients cannot afford the medicines that could treat their cancer, autoimmune disorders, and chronic diseases. Regulators can change that by eliminating redundant biosimilar trials when rigorous scientific evidence already establishes similarity.
Every unnecessary study adds costs, delays competition, and keeps life-saving medicines beyond patients’ reach. This is no longer merely a pharmaceutical policy debate. It is a test of whether our regulatory systems serve patients or protect the status quo.
Biologic medicines, produced using living systems, have transformed modern medicine. The U.S. Food and Drug Administration (FDA) defines biosimilars as highly similar to approved biologic medicines, with no clinically meaningful differences in safety, purity, and potency.
They can offer more affordable treatment options, although lower prices are not guaranteed. Yet development remains expensive, and access is deeply unequal.
If roughly one-third of the global population lacks regular access to essential medicines, as reported by the World Health Organization (WHO), access to advanced biologic treatments is an even greater challenge. Even in wealthy countries, uninsured and underinsured patients face impossible choices between treatment and financial survival.
The science has advanced. Regulation must catch up.
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FDA Biosimilar Reform
In March, the FDA announced draft recommendations to streamline certain pharmacokinetic (PK) testing requirements, estimating potential savings of up to 50 percent in study costs, or approximately $20 million.
This followed its October 2025 draft guidance recommending that comparative efficacy studies may be unnecessary when other evidence adequately establishes biosimilarity.
These are important steps, but they must become part of a broader international commitment to evidence-based regulation. According to the FDA, biologics accounted for 51 percent of U.S. drug spending in 2024 despite representing just 5 percent of prescriptions.
No Need to Answer a Question That's Been Answered
That announcement is a signal, but draft guidance is not enough. Regulators worldwide must turn this principle into consistent rules, timelines, and transparent decisions that patients and manufacturers can rely upon.
A clinical trial is ethical only when it can meaningfully improve our understanding or change a regulatory decision. Modern analytical methods can compare a biologic’s molecular structure, purity, and functional properties with extraordinary precision. PK studies can establish how a medicine moves through the body. If these findings, alongside appropriate safety and immunogenicity assessments, establish biosimilarity, another efficacy trial may add little useful information.
Consider this. Weigh a diamond on a high-precision electronic balance, then weigh it on a household bathroom scale. The second measurement does not improve the first. It introduces uncertainty. Why should medicine demand an equivalent exercise when better scientific evidence already answers the question?
I am not arguing that every trial is unnecessary. Residual uncertainty must be investigated, and safety cannot be negotiated away. But testing patients merely to complete an administrative checklist is not rigor. It is a misuse of science, time, and human participation.
Cost of Unnecessary Trials
The consequences are not theoretical. Oncology patients and people with severe chronic illnesses can spend years waiting for affordable alternatives while manufacturers absorb enormous development costs. Studies that add little meaningful information can cost tens of millions of dollars. Those expenses become barriers to entry, discouraging smaller manufacturers and protecting established brands from competition.
We have seen this pattern before. Genetic engineering once provoked dire predictions and fierce resistance. Yet biotechnology advanced, generic competition expanded, and the pharmaceutical landscape changed. Biosimilars should follow the same trajectory. When more qualified manufacturers enter a market, competition can force prices down and make essential treatments accessible to more people.
Imagine a different future where regulators assess the totality of evidence, manufacturers invest in efficient production, and multiple suppliers compete on quality and price.
Medicines that are financially impossible today could become routine treatment tomorrow. The alternative is a system in which preventable suffering continues because institutions confuse caution with repetition, while patients pay for the delay.
Regulatory Change
The FDA, the European Medicines Agency, and other regulatory authorities must now act. 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. Patient groups and lawmakers should press regulators to measure success by safety, access, development time, and competition, not by the number of tests completed.
A biosimilar delayed is a biosimilar denied. Every day of avoidable delay has a human cost. We already possess the scientific tools to do better. Regulators must use them, because patients deserve evidence-based decisions, not bureaucratic endurance tests.
Dr. Sarfaraz K. Niazi is a pharmaceutical scientist, author, inventor, and affiliate professor at Washington State University. His work focuses on biosimilars, biotechnology, and drug development.
The views expressed in this article are the writer’s own.