AAM and Biosimilars Council praise FDA plan to simplify biosimilar development

WASHINGTON — The Association for Accessible Medicines and its Biosimilars Council praised FDA's updated guidance to reduce costs and streamline biosimilar development. The FDA now allows originators to cite existing comparative data, not just from the U.S., for clinical pharmacokinetic testing comparing biosimilars to reference biologics. It also removes the need 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, along with recent FDA actions such as the October 2025 guidance on reducing the need for comparative efficacy studies, clearly shows that FDA’s thinking continues to develop positively. This guidance will assist biosimilar developers in entering the market more quickly, speeding up 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 2024, titled "Streamlining the Development of Biosimilar Medicines," arguing that scientific advances and regulatory discretion can help streamline biosimilar development. It also recommended updated guidance on avoiding unnecessary comparative efficacy studies and three-way PK comparisons. Both considerations are now regarded as common-sense approaches by the FDA as manufacturers develop biosimilars.