AAM And Biosimilars Council Comment On GDUFA And BsUFA User Fee Negotiations And Reauthorization

The Association for Accessible Medicines and the Biosimilars Council today released the following statement from President and CEO John Murphy III on recent GDUFA and upcoming BsUFA public meetings, negotiations, and Congressional Reauthorization.

“With the GDUFA IV public meeting now behind us and as stakeholders prepare for the upcoming BsUFA IV public meeting, we have an important opportunity to recognize the progress made through both user fee programs and what these agreements can mean for patients.

Generic and biosimilar medicines are fundamental to a competitive and sustainable U.S. health care system, delivering significant savings while expanding access to affordable treatment options. GDUFA and BsUFA provide FDA with critical resources and establish the performance commitments necessary to support efficient, predictable, and science-based regulatory pathways for these medicines.

The proposed GDUFA IV agreement includes meaningful and pragmatic improvements designed to make the ANDA assessment process more efficient and predictable, improve communication between FDA and applicants, address scientific and regulatory issues earlier in the review process, support the development of complex generics, and better integrate inspections and manufacturing considerations into the application lifecycle. These enhancements were agreed upon with the intent to help reduce unnecessary review cycles and support more timely generic drug approvals.

Similarly, BsUFA IV represents an opportunity to continue modernizing the biosimilar development and review process. Greater regulatory efficiency, improved sponsor-FDA communication, appropriate use of advances in analytical science, and a predictable review process can reduce unnecessary development burdens while maintaining FDA’s rigorous standards for safety, purity, and potency.

Together, GDUFA IV and BsUFA IV represent an important commitment by FDA and industry to continually improve the regulatory framework for generic and biosimilar medicines. A strong FDA, adequately resourced and focused on efficient, science-based regulation, is essential to fostering competition and ensuring patients have timely access to safe, effective, and affordable medicines.

AAM and the Biosimilars Council looks forward to working with Congress to ensure timely reauthorization of GDUFA and BsUFA.”

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. For more information, visit biosimilarscouncil.org.