Industry responds to Biosimilar User Fee Act letter


SILVER SPRING, Md. — The Food and Drug Administration on Friday released the Biosimilar User Fee Act (II) performance goals letter, drawing support from trade groups representing biotechnology companies. 


The letter includes key provisions around improving the efficiency of the FDA review process for biosimilars, promoting engagement between the FDA and biosimilar manufacturers during the development and review process to ensure timely feedback and establishing a dedicated staff capacity for key functions, including facilitating scientific coordination, policy development, operations management, program governance and others. The letter also seeks to help modernize time reporting and capacity planning. 


“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 Pharmaceutical Research and Manufacturers of America said. “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.”


In addition to PhRMA, the letter gained support from the Biotechnology Innovation Organization (BIO), which was “particularly pleased with the Agency’s commitment to establish a program for enhanced communications during the biosimilars review process,” noting that a similar program under the Prescription Drug User Fees Act has been successful in improving communications during the development and approval process.


“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,” BIO said. “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.”


Both groups said they looked forward to working with the agency, the administration and Congress to reauthorize the act in a timely manner. 


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