FDA draft guidance removes redundant PK testing requirements where scientifically rigorous data already exists

WASHINGTON (March 10, 2026) — The Association for Accessible Medicines and its Biosimilars Council today lauded FDA updated guidance to streamline and lower costs to develop biosimilar medicines. The FDA is updating and modernizing their guidance to allow originators to cite existing comparative data, not exclusively from the United States, for clinical pharmacokinetic testing which compares a proposed biosimilar against the approved reference biologic medicine. It also removes the requirement for duplicative comparative studies.

“AAM and the Biosimilars Council thank Dr. Makary and the FDA for updating their guidance on biosimilar development,” said John Murphy III, President and CEO of the Association for Accessible Medicines. “We applaud the FDA as they continue to trust the science and advocate for streamlining biosimilar development, which will help biosimilar developers bring high quality biosimilars to patients more quickly. Generic and biosimilar medicines are the single largest driver of prescription drug affordability in the U.S. and in 2024 alone generated $467 billion in savings for patients and the health care system.”

This updated guidance in conjunction with recent FDA actions, such as the October 2025 guidance on limiting the need for comparative efficacy studies, is a clear sign that FDA’s thinking continues to evolve in a positive direction. This guidance from the FDA will help biosimilar developers enter the market faster, accelerating access to lower cost treatment options for America’s patients.

“The Biosimilars Council has been raising alarm bells for some time about the biosimilars void,” said Alex Keeton, Executive Director of the Biosimilars Council. “Over the next decade, over 100 biologic medicines will come off patent, yet for around 90% of those medicines, there is currently no biosimilar in development. Biosimilars save our health care ecosystem over $20 billion a year, and those savings will be lost without a certain and predictable development and approval process. Thank you to the FDA for implementing common sense regulatory enhancements to lower drug costs for patients by modernizing biosimilar medicines development. With continued efforts like these, we can escape the biosimilar void.”

The Biosimilar Council released a paper in May of 2024, Streamlining the Development of Biosimilar Medicines, arguing that scientific advances and regulatory discretion can help streamline biosimilar development and recommended updated guidance on unnecessary comparative efficacy studies, and unnecessary three-way PK comparisons. Both considerations are now considered as a commonsense approach by the FDA as manufacturers consider biosimilar development.

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Biosimilars Void Paper: https://biosimilarscouncil.org/news/biosimilar-void-crisis-in-patient-access-iqvia-report

White Paper – Streamlining the Development of Biosimilar Medicines: https://biosimilarscouncil.org/wp-content/uploads/2024/05/202405-BiosimilarsCouncil-Streamlining-Development-Biosimilar-Medicines.pdf

Biosimilars Council Calls for More Efficient Regulatory Pathways for Critical Medicines: https://biosimilarscouncil.org/news/biosimilars-council-calls-efficient-regulatory-pathways-critical-medicines

Blog: What Are Interchangeable Biologics? https://biosimilarscouncil.org/resource/what-are-interchangeable-biologics

AAM Advocacy Priorities: https://accessiblemeds.org/wp-content/uploads/2025/02/AAM-Protect-and-Defend-Patient-Access-Generics-Biosimilars.pdf

U.S. Generic & Biosimilar Medicines Savings Report: https://accessiblemeds.org/resources/reports/2025-savings-report

Media contact: media@accessiblemeds.org

About AAM

The Association for Accessible Medicines, your generics and biosimilars industry, is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. AAM represents the manufacturers of finished generic pharmaceuticals and biosimilars, manufacturers of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 12 percent of total drug spending.

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines, works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is the leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, government affairs, legal affairs, and regulatory policy. More information is available at www.biosimilarscouncil.org.