Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl issued the following statement on the release of the Biosimilar User Fee Act (II) performance goals letter:

"The Biosimilar User Fee Act (BsUFA) is critical to supporting the U.S. Food and Drug Administration (FDA) in its core mission of protecting public health. Since its creation in 2012, BsUFA has helped benefit patient safety and public health as biosimilar products are required to meet FDA's high standards for safety, purity and potency. The BsUFA II agreement will help provide FDA with the resources needed to enhance the science-based review of new biosimilars, which will help increase competition in the marketplace to the benefit of patients.

"With the successful conclusion of the BsUFA II technical negotiations between the FDA and the biopharmaceutical industry, PhRMA looks forward to working with Congress, the administration, patient and medical provider groups, the FDA and all stakeholders to ensure timely reauthorization of this vital program." 

Key provisions about the BsUFA II performance goals letter:

• Continue to improve the efficiency of the science-based FDA review process for biosimilars;
• Promote more informative engagement between FDA and biosimilar sponsors during development and review of biosimilar products, for example by helping to ensure feedback is provided in a timely manner;
• Establish dedicated staff capacity for key functions, such as facilitating scientific coordination, policy development, operations management, program governance, internal training, educational outreach, and communication; and
• Help ensure the long-term sustainability of BsUFA activities through modernized time reporting and capacity planning.