Biosimilars Forum Submits comments on FDA Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 through 2022

Washington, DC, October 20, 2016 – The Biosimilars Forum – the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States today submitted comments on FDA Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 through 2022.

Additionally, Julie Reed, the Biosimilars Forum’s President, represented the Forum on the Industry Stakeholder panel during today’s Biosimilar User Fee Act Public Meeting at the Food and Drug Administration (FDA) and presented the Forum’s position as reflected in the full comments, which are excerpted below.

“In the BsUFA II Commitment Letter, the FDA outlines significant enhancements to the 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 is expected to 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 biosimilars staffing; 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.

“The Forum applauds the efforts made by the FDA to work with industry toward a more efficient and transparent review process. The Forum believes the negotiations resulted in improvements in communication and accountability between sponsors and FDA, and the focusing of the industry’s contributions of BsUFA funds on matters related to the FDA’s biosimilars review program. The goals set out in the Commitment Letter will help ensure timely and more transparent review of biosimilar products, to the benefit of patients who need these products.”

The Biosimilars Forum encourages Congress to support the BsUFA II agreement and also to provide the FDA with the necessary funding it needs to continue building this program. The commitments by the FDA, combined with the financial support of Congress and industry ultimately will benefit patients by getting these important products to market.

The Forum’s full comments can be viewed here.

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