Placeholder Banner

BIO Statement on Biosimilar User Fee Act Goals Letter

September 26, 2016

Washington, D.C. (September 16, 2016) – Biotechnology Innovation Organization (BIO) Senior Vice President for Science Policy Kay Holcombe released the following statement today regarding the Biosimilar User Fee Act (BsUFA) II goals letter:

“BIO and our member companies strongly supported the establishment of a pathway for the approval of biosimilars because we recognized that market entry of safe and effective biosimilars may provide increased choices for patients and physicians. We remain committed to ensuring the success of the emerging biosimilars market through our engagement in ongoing policy developments related to biosimilars, including our recent participation in the technical negotiations for the reauthorization of BsUFA.

“The goals and commitments reflected in the thoughtful and carefully negotiated BsUFA II goals letter will expand and build upon the initial success of BsUFA I by ensuring that the FDA has the resources necessary to review biosimilar biological products in an efficient and timely manner while maintaining the Agency’s high standards for safety and efficacy and by making structural modifications that will enhance the operation of the biosimilars user fee program.

“Among the many enhancements to the biosimilars review process envisioned in the goals letter, we are particularly pleased with the Agency’s commitment to establish a program for enhanced communications during the biosimilars review process. A similar program in PDUFA has been tremendously successful in improving communications between Sponsors and the Agency at key points in the development process, resulting in a more efficient process for sponsors and the FDA alike.

“We also applaud the Agency’s commitment to implement a new time reporting system and to enhance financial transparency, to provide more accurate data on which to base accurate tracking of the use of BsUFA resources and a clear picture of that resource allocation.  The commitments to improve FDA recruitment, hiring and retention of staff necessary to accomplish the goals of the biosimilars program are significant and crucial to the program’s success.

“We look forward to working with Congress, the administration, patient and provider groups, and all stakeholders to ensure that BsUFA is reauthorized in a timely manner and that the important enhancements to the program laid out in the goals letter are implemented most effectively.”

Upcoming BIO Events 

BIO Animal Biotech Summit

September 21-23, 2016

Bethesda, MD


BIO IP & Diagnostics Symposium

September 29, 2016

Alexandria, VA

BIO Investor Forum

October 18-19, 2016

San Francisco, CA


BIO Latin America Conference

October 26-28, 2016
Grand Hyatt São Paulo, Brazil



Discover More
Collaboration has evolved for more than two decades   
Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), released the following statement in response…
Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), sent a letter to President Joe Biden yesterday suggesting the establishment of a COVID Global Strategy for Harnessing Access Reaching Everyone (SHARE)…