FDA Releases Biosimilar Guidance Pushing to Streamline Development

According to the FDA’s updated recommendations for demonstrating biosimilarity, a comparative analytical assessment (CAA) may be more effective in detecting differences between products than a comparative efficacy study (CES).¹

“Biosimilars are often far more affordable to patients and have the promise to significantly lower health care costs in America,” said FDA Commissioner Marty Makary, MD, MPH, according to a news release.² “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.”

These monumental revisions––a decade in the making––to the FDA’s process in demonstrating biosimilar drugs were announced Wednesday during a US Department of Health and Human Services press conference.³ The official document laying out the FDA’s plans to streamline biosimilar development is a direct update to the agency’s published guidance from April 2015.¹

READ MORE: White House Announces Action to Increase Competition, Decrease Cost of Biosimilar Development

The initial document was intended to provide general guidance on biosimilar development and the need to conduct clinical studies for the proposed biosimilar product to receive a marketing application. However, the most recent update is reversing this need for clinical trials. It argues that the advanced technology currently available at the FDA can detect minor differences between biosimilars and their intended reference products more effectively than clinical trials.^1,4

Although this change has the potential to bring biosimilars to market more quickly and efficiently, it does not entirely remove the need for trials or CESs. With the new guidance, the FDA provided 3 distinct conditions under which a biosimilar can have a CES waived for a CAA.

First, a CES is not necessary if the biosimilar and reference product are highly purified and can be well characterized in an analytical test. According to the FDA’s guidance, these highly purified products can model effects with a higher degree of specificity and sensitivity through the use of biological and biochemical assays.¹

A CES will also not be necessary if the quality and clinical efficacy can be well understood after a CAA. Finally, if a pharmacokinetic (PK) similarity study is feasible and has clinically meaningful data, biosimilars can also bypass the need for a CES.^1,4

“The administration rightfully recognizes the importance of developing biosimilars efficiently based on science—rather than being slowed down by bureaucracy. Since 2015, the FDA has approved more than 70 biosimilars, and the agency can now rely on the latest science and processes to approve biosimilars in a streamlined fashion,” Juliana Reed, executive director of the Biosimilars Forum, said in a statement.⁵ “A typical biosimilar costs $100 million to $300 million to develop and takes 6 to 9 years to go from the initial stages of development to FDA approval—requiring a major investment from US companies. Our members take immense pride in this investment, and they must ensure their products are approved with efficiency to reach Americans [who] need them.”

Above all, the FDA recognizes that all proposed biosimilars and their corresponding molecules require personalized approaches in determining whether a CAA, CES, or PK study is the most suitable avenue for development. The agency concluded its recommendations by identifying instances when a CES will still be necessary; for instance, when a PK study is not feasible, specifically for locally acting products.

Although each potential biosimilar product will still require the proper testing and understanding before hitting the market, many experts agree that the new approach will benefit several players within the drug development process, including patients, providers, and manufacturers.

“Science continues to evolve, and the FDA remains committed to advancing common-sense policies that further promote efficient and effective biosimilar and interchangeable biosimilar development, without compromising safety and effectiveness,” concluded George F. Tidmarsh, MD, PhD, director of the FDA Center for Drug Evaluation and Research.²

READ MORE: White House Strikes Deal with Pfizer for Lower Drug Prices, Online DTC Website

REFERENCES

1. Scientific considerations in demonstrating biosimilarity to a reference product: updated recommendations for assessing the need for comparative efficacy studies. FDA. October 2025. Accessed October 31, 2025. https://www.fda.gov/media/189366/download

2. FDA moves to accelerate biosimilar development and lower drug costs. News release. FDA. October 29, 2025. Accessed October 31, 2025. https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs

3. Nowosielski B. White House announces action to increase competition, decrease cost of biosimilar development. Drug Topics. October 29, 2025. Accessed October 31, 2025. https://www.drugtopics.com/view/white-house-announces-action-to-increase-competition-decrease-cost-of-biosimilar-development

4. Jeremias S. A closer look at new FDA guidance removing barriers to biosimilar development. The Center for Biosimilars. October 30, 2025. Accessed October 30, 2025. https://www.centerforbiosimilars.com/view/a-closer-look-at-new-fda-guidance-removing-barriers-to-biosimilar-development

5. Biosimilars Forum applauds FDA and Commissioner Dr Marty Makary for supporting safe, effective and lower-cost biosimilars. Biosimilars Forum. Accessed October 31, 2025. https://biosimilarsforum.org/2025/10/29/biosimilars-forum-applauds-fda-and-commissioner-dr-marty-makary-for-supporting-safe-effective-and-lower-cost-biosimilars/