FDA to Ease Rules for Approving Low-Cost Biosimilar Drugs

FRIDAY, Oct. 31, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) announced Wednesday that it will relax certain regulations for approving biosimilars, or low-cost alternatives to expensive biologic drugs.

The decision is aimed at accelerating access to cheaper treatments for patients while cutting down on costly and time-consuming clinical trials.

Biosimilars are nearly identical versions of biologic medicines — drugs made from living cells — used to treat serious conditions such as cancer, diabetes, and autoimmune diseases.

They are similar in purpose to generic drugs but are more complex to manufacture.

What the New Guidance Changes

Under the FDA’s updated guidance, biosimilar manufacturers will no longer be required to conduct lengthy human clinical trials to prove their products are as effective as their brand-name counterparts.

Instead, companies must now demonstrate that their molecular structure and manufacturing processes closely match those of the original biologic.

According to The New York Times, the change could cut approval timelines in half, reducing the process from five to eight years down to just a few years.

FDA Commissioner Dr. Marty Makary said this shift will not compromise safety or efficacy but will reduce costs for drug developers — savings that could ultimately lower prices for patients.

Greater Flexibility for Pharmacists

The FDA also plans to make it easier for pharmacists to substitute biosimilars for brand-name drugs, similar to how they already do with generic medications. This would simplify access for consumers and potentially expand the use of biosimilars across pharmacies nationwide.

Industry and Government Reactions

“For too long, government bureaucracy and regulatory barriers have protected monopolies and stifled competition,” said U.S. Health Secretary Robert F. Kennedy Jr. during a press conference announcing the reform.

He accused major pharmaceutical companies of “rigging the rules” to protect profits and prevent competition from lower-cost biosimilars.

Industry analysts cautiously welcomed the move but noted that patent protections and legal tactics by brand-name drugmakers often pose bigger barriers than FDA rules.

“I don’t really see this regulatory change as an alleviation of the real bottleneck,” said Brian Skorney, a drug industry analyst with investment bank Baird. “The core issue remains the ability of big pharma to use patents and lawsuits to delay competition.”

Background on Biosimilars

Since the FDA approved the first biosimilar in 2015, more than 60 biosimilar drugs have entered the U.S. market. Despite this, adoption has been slow due to complex regulations and legal hurdles.

Top-selling biologic drugs already have biosimilar competitors, including Herceptin (for breast cancer), Lantus (for insulin management), and Humira (for arthritis and autoimmune disorders).

According to The Times, generic and biosimilar drugs now make up about 90% of prescriptions in the United States, but they account for only a fraction of total prescription drug spending — underscoring how expensive biologic drugs remain a key driver of rising healthcare costs.

Pushback From the Pharmaceutical Industry

The pharmaceutical industry’s main lobbying group, PhRMA, pushed back against the FDA’s announcement, arguing that pharmacy benefit managers (PBMs) — companies that negotiate drug prices — are also responsible for limiting biosimilar access.

Kennedy responded by saying that large pharmaceutical corporations have long manipulated the system to maintain high prices and discourage competition. “The pharmaceutical industry rigged the rules,” he said.

Looking Ahead

FDA officials hope the new policy will stimulate competition, reduce drug costs, and encourage innovation in biosimilar development. With faster approval timelines and fewer regulatory hurdles, patients may soon see more affordable treatment options for chronic and life-threatening diseases.

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