10/26/2026
A biologic is a medicine made from living cells or natural biological materials through complex manufacturing processes, designed to target specific diseases such as cancer, autoimmune disorders or rare genetic conditions. Biosimilars are biologics that are highly similar to and have no clinically meaningful differences in safety, purity, or potency from already-approved biologic medicines. These medicines play an important part in the competitive U.S. medicines marketplace by expanding treatment options for patients.
The big picture: In 2012, Congress passed the Biosimilar User Fee Act (BsUFA), creating a program that supplements Congressional budgetary authority to support the regulatory review of biosimilar medicines. The goal of the BsUFA program is to make the review process timely and more predictable so safe and effective biosimilars can reach patients sooner.
Since then, BsUFA has strengthened the FDA’s biosimilar regulatory review program, supporting timely development of biosimilar products. BsUFA helps advance the dual goal of both more biosimilars in the marketplace providing more treatment options for patients and, correspondingly, more competition.
What’s new:
- Every five years, the FDA and industry negotiate an agreement for the next reauthorization of BsUFA, with input from patient groups and other stakeholders.
- The negotiation process just concluded for BsUFA IV and the FDA is preparing to send the commitment letter to Congress for reauthorization.
- On October 26, 2026, the FDA will hold a public meeting to discuss the proposed recommendations for the reauthorization of BsUFA IV.
What will BsUFA IV do? The BsUFA IV agreement builds on the foundation of previous reauthorizations with targeted improvements designed to strengthen review efficiency and improve sponsor-FDA communication to reduce delays and increase accountability.
1. A stronger focus on review efficiency. BsUFA IV includes new tools to help facilitate first-cycle reviews and approvals and create greater predictability for biosimilar developers. For example, the proposed BsUFA IV commitment letter includes a commitment for the FDA to review certain study protocols within specified timelines.
2. More meaningful FDA-sponsor engagement. The agreement creates additional opportunities for communication between the FDA and biosimilar sponsors, including earlier engagement on manufacturing and facility issues that can delay approvals if identified too late in the review process.
3. Greater transparency and accountability. BsUFA IV introduces independent third-party assessments to evaluate FDA performance and identify opportunities for improvement. These provisions help ensure the program remains focused on delivering timely, high-quality reviews for patients and sponsors alike.
The stakes: BsUFA supports the timely FDA review of biosimilars while preserving the agency’s rigorous standards for safety, effectiveness and quality. Congress should move quickly to reauthorize the agreement before BsUFA III expires on September 30, 2027.
The bottom line: BsUFA, along with a supportive regulatory and policy environment, helps facilitate biosimilar development. An efficient regulatory pathway and predictable review process help companies make investments in biosimilar development, supports competition and, ultimately, helps patients gain access to more treatment options.
