The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses.

These policies include “major updates to simplify biosimilarity studies and reduce unnecessary clinical testing” and “a separate initiative...to make it easier for biosimilars to be developed as interchangeable with brand-name biologics,” the agency stated in a recent press release.

How Does the FDA Plan to Streamline the Biosimilar Drug Approval Process?

A draft guidance issued by the FDA in October for “comment purposes only” provides updated recommendations for industry on assessing the need for comparative efficacy studies (CESs) for biosimilar agents.

“Generally, if the [comparative analytical assessment] supports a demonstration that the proposed biosimilar is highly similar to its reference product...an appropriately designed human pharmacokinetic similarity study and an assessment of immunogenicity may be sufficient to evaluate whether there are clinically meaningful differences between the proposed biosimilar and the reference product,” according to the guidance document.

In such cases, the agency recommends that “sponsors consider a streamlined approach where a CES may not be necessary to support a demonstration of biosimilarity.”

Why Is the FDA Proposing These Changes?

“Biosimilars are often far more affordable to patients and have the promise to significantly lower healthcare costs in America,” FDA Commissioner Marty Makary, MD, explained in the press release. “By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions of Americans.”

Congress established the approval pathway for biosimilars in 2010 through the Biologics Price Competition and Innovation Act.

“Since then, the FDA has approved 76 biosimilars that provide Americans additional treatment options for conditions such as cancer, rheumatoid arthritis, diabetes, Crohn’s disease, and osteoporosis,” but this corresponds to “a small fraction of approved biologics,” the agency noted.

Biosimilars make up just 5% of prescriptions in the United States but accounted for 51% of total drug spending in 2024. Further, their market share remains below 20%, and “[o]nly about 10% of brand-name biologic drugs that will lose patent protection in the next decade currently have a biosimilar in development.”

By contrast, more than 30,000 generic drugs for nonbiologics have been approved, which exceeds the number of approved brand drugs.

Will These Changes Benefit Patients?

The FDA contends that the proposed changes will lower costs for both industry sponsors and patients and that making it easier to use biosimilars and their reference products interchangeably will help patients and pharmacists more often choose lower-cost options.

A recent analysis showed that the entry of biosimilars to the market does indeed lead to modest price reductions, but the savings “remained less than those achieved by small-molecule genetics.”

The investigators looked at how the prices of seven brand-name biologic agents reimbursed under Medicare Part B were affected by the entry of biosimilar agents to the market and found overall price reductions of 7.4% at 1 year, 31.7% at 3 years, and 43.1% at 5 years. However, the effects varied widely across agents.

Lead investigator Aaron P. Mitchell, MD, MPH, and his colleagues concluded that the findings highlight the need for policy reforms to enhance market competition and promote cost reductions. In an interview, Mitchell said the FDA’s recommendations, with proper implementation, could help achieve this goal.

“In general, biosimilars are good for patients,” said Mitchell, a genitourinary medical oncologist and health policy researcher at Memorial Sloan Kettering Cancer Center in New York City.

“I would want to be assured that no one is taking their eye off the ball and that they are doing testing rigorously, but in theory, it’s a step I’m okay with,” he said. “If studies are well done and rigorous, and we see that biochemically [the biosimilar] looks exactly the same, it makes sense.”

The proposed changes could reduce regulatory burden, reduce upfront costs, and speed up the process of getting biosimilars to the market at lower costs, Mitchell added.

Others, however, have expressed greater concerns regarding the recent FDA proposals.

In response to a September 19, 2025, public FDA workshop on advancing the development of interchangeable products, the Alliance for Safe Biologic Medicines (ASBM) submitted detailed comments to the FDA expressing strong concern over what the organization called “genericizing” of biosimilars.

The ASBM stated that the proposed shift would be “scientifically inappropriate and potentially harmful to patient confidence” and urged the FDA “to regulate in a manner consistent with the long-recognized scientific fact that biosimilars are not generics.”

“This fact has been clearly acknowledged by both FDA and [European Medicines Agency] and guided the tailoring of a regulatory framework that supports a shortened approval pathway consistent with the science. We support maintaining FDA’s flexible, case-by-case interchangeable biosimilar approval framework, which permits use of analytical and clinical data — including switching studies when appropriate — to ensure strong physician and patient confidence in substitution decisions,” ASBM added.

The organization also argued that “comparative clinical studies should remain available tools that strengthen prescriber trust, not be abandoned in pursuit of regulatory speed.”

What Happens Next?

Comments on the September FDA workshop closed as of October 19, 2025, and the FDA reported that the input received “will inform the development of a draft strategy document that outlines specific actions FDA will take to facilitate the development of interchangeable biosimilar products and that FDA will publish, for public input, within 12 months following the workshop.”

The draft guidance aimed at speeding up biosimilar drug development was officially published on November 20, 2025, and comments will be accepted until January 20, 2026.

Mitchell had no disclosures.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape Medical News, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X: @SW_MedReporter.