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Biosimilars Forum Applauds Outcome of BsUFA Negotiations; Pleased to Have Played Important Role in Decision-Making

Washington, DC, September 16, 2016 – The Biosimilars Forum – the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States today issued a statement regarding the recently concluded BsUFA negotiations.

“The Biosimilars Forum applauds the outcome of the negotiations and believe that the final agreement reflects the Forum’s overriding goal to provide our ongoing support to this important program that will benefit patients by advancing biosimilar approvals in the US. The agreement demonstrates improvements in communication and accountability between sponsors and FDA, and the focusing of the industry’s contributions of BsUFA funds on matters supporting to the FDA’s biosimilars review program. 

“The Forum is pleased to have played a part in the negotiations and successfully advocate for program enhancements that provide the FDA with some of the necessary resources to support the biosimilar program. The agreement will help ensure timely and more transparent review of biosimilar products and advance their approvals. We encourage Congress to support the agreement and to provide the FDA with the necessary government resources it needs to build their biosimilar program to help our industry bring these important products to market to benefit the patients who need them.”


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.

Contact:
Aimee Steel Lubin
202.828.1895
aimee.lubin@hklaw.com

Media:
Lynn Blenkhorn
508.851.0930
biosimilars@fkhealth.com

Date

Friday, September 16, 2016