FDA to Ease Copycat Drug Rules, Speeding Access to Cheaper Drugs

Key Takeaways

• Federal regulators will no longer require costly clinical trials for most biosimilars, speeding up approval

• The change could cut timelines in half and save drugmakers tens of millions in costs

• Officials say this will boost competition and lower drug prices for patients

FRIDAY, Oct. 31, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) announced Wednesday that it will relax certain rules for approving low-cost versions of some high-priced medications, in an effort to speed up access to cheaper alternatives.

The decision affects biosimilars — medicines that are near-identical copies of biologic drugs made from living cells. 

These drugs are similar to generics but more complex to produce. They’re often used to treat serious conditions like cancer, diabetes and autoimmune diseases.

Several top-selling brand-name drugs already have biosimilar versions, including Herceptin for breast cancer, Lantus for insulin and Humira for arthritis and other autoimmune disorders.

Under the new guidance, biosimilar developers will no longer be required to conduct expensive and lengthy clinical trials to prove that their version is as effective as the original, according to The New York Times. 

Instead, they’ll just need to show that the drug’s structure and manufacturing process are similar to the brand-name version.

The FDA also plans to make it easier for pharmacists to substitute biosimilars for brand-name drugs, similar to how they can with generic ones.

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

FDA Commissioner Dr. Marty Makary said the changes could cut the approval timeline in half, from the current five to eight years, and save companies tens of millions of dollars in research costs. He said those savings could ultimately lower prices for patients.

Industry experts said the move could help, but might not solve the biggest roadblocks keeping biosimilars from reaching customers. 

Brand-name drugmakers have long used patent protections and lawsuits to delay biosimilar launches, even after FDA approval.

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“I don’t really see this regulatory change as an alleviation of the real bottleneck,” Brian Skorney, a drug industry analyst at investment bank Baird, said.

Currently, generic and biosimilar drugs make up about 90% of prescriptions in the U.S., yet they account for only a small share of total drug costs, The Times reported. 

Biologic drugs, which biosimilars are designed to replace, remain a major driver of rising drug spending.

PhRMA, the lobbying group for brand-name drugmakers, pushed back on Wednesday, saying pharmacy benefit managers — middlemen who negotiate drug prices — are also to blame for limiting biosimilar access.

Kennedy also accused major pharmaceutical companies of lobbying to rig the rules and protect their profits. 

“The pharmaceutical industry rigged the rules,” he said.

Since the first biosimilar was approved in 2015, more than 60 have entered the U.S. market, but the process has been slow. FDA officials say this new initiative aims to change that by making the process faster and cheaper for both patients and drugmakers.

More information

The American Cancer Society has more on biosimilar medicines.

SOURCE: The New York Times, Oct. 29, 2025

What This Means For You

The new policy could soon make lifesaving biosimilar drugs more affordable and widely available.