Past President of Biosimilars Forum Testifies before Congress Regarding BsUFA

WASHINGTON, March 2, 2017—Today, Juliana Reed, Vice President of government affairs for Coherus BioSciences, Inc. and the Immediate Past President of the Biosimilars Forum, the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States, testified before the House Energy and Commerce Committee Subcommittee on Health regarding the reauthorization of the Biosimilars User Fee Act (BsUFA). An excerpt of her statement is below. Read her full statement here.

“The Biosimilars Forum appreciates the opportunity to testify today regarding its participation in the negotiations for the BsUFA program for FY2018 – FY2022 (BsUFA II) and to provide our perspective on the reauthorization of the user fee program legislation. We urge Congress to support the outcome of BsUFA II negotiations and to reauthorize the program prior to September 30, 2017.”

“Within BsUFA II, there are significant enhancements to the Biosimilar User Fee program that support the review and approval of biosimilar medicines in the U.S. These agreed-to enhancements include:

  • A revised review process meant to increase transparency and communication between the FDA and biosimilars sponsors that will facilitate an increase in the likelihood of first-cycle approval;
  • Agency commitments to complete and publish several draft and final guidance documents that will provide industry with additional clarity and certainty regarding the biosimilars development and review process;
  • Agency commitments to augment and strengthen staffing of the biosimilars program, including hiring product reviewers; and
  • Enhancements to the user fee structure and management that will allow greater transparency, predictability and long-term stability of biosimilar development programs in the U.S.

“We encourage Congress to support the BsUFA reauthorization and to provide the FDA with the necessary government resources it needs to continue building its biosimilar program. The commitments made by the FDA, combined with the financial support of Congress and industry ultimately will benefit patients by getting these important products to market.”

About the Biosimilars Forum

The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.

To learn more about biosimilars, the Forum, and how to get involved, visit or go to @USBiosimilars to follow related conversations and join the dialogue.

Aimee Steel Lubin

Lynn Blenkhorn