PhRMA Issues Statement on Biosimilar User Fee Act IV Performance Goals Letter
核心洞察
PhRMA (搜索) President and CEO Stephen J. Ubl issued a statement on the release of the Biosimilar User Fee Act (BsUFA) IV Performance Goals Letter.
PhRMA (搜索) said BsUFA IV focuses on improving FDA review efficiency and ensuring resources support timely review of safe and effective biosimilars (搜索).
The agreement adds FDA-sponsor communication opportunities and transparency, and PhRMA (搜索) urged Congress to move swiftly to reauthorize the program.
PhRMA (搜索) has issued a statement on the release of the Biosimilar User Fee Act (BsUFA) IV Performance Goals Letter, saying the agreement builds on the program's role in supporting an efficient, predictable and science-based FDA review process for biosimilars (搜索) since it was established in 2012.
According to the statement, BsUFA IV focuses on enhancing the FDA's core review functions by improving review efficiency and ensuring the agency's resources are used effectively to support timely review of safe and effective biosimilars (搜索). The agreement also enhances opportunities for communication between the FDA and biosimilar sponsors throughout the review process and increases transparency.
PhRMA (搜索) said these improvements are intended to ensure a predictable and effective regulatory pathway supporting continued biosimilar development and timely patient access, and encouraged Congress to move swiftly to reauthorize BsUFA. The organization describes biosimilars (搜索) as an important part of a competitive U.S. medicines marketplace that help lower health care costs and expand treatment options.