Biosimilar User Fee Act goals letter gets support from PhRMA and BIO

Commenting on the release last week of the Biosimilar User Fee Act (II) performance goals letter, trade group Pharmaceutical Research and Manufacturers of America (PhRMA) president and chief executive Stephen Ubl welcomed the move, saying: "The Biosimilar User Fee Act (BsUFA) is critical to supporting the US Food and Drug Administration (FDA) in its core mission of protecting public health.”

He continued: “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," he stated.