PhRMA Statement on Biosimilar User Fees

(Ref: PhRMA)

Washington, D.C. (December 6, 2011) —Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President Sascha Haverfield-Gross today issued the following statement about user fees for biosimilars:

“PhRMA is pleased that the Food and Drug Administration (FDA) has announced plans to solicit stakeholder input at an upcoming public meeting about the proposed user fees and performance goals for biosimilars. We endorse a clear, science-based, separately funded regulatory program for biosimilars that is supported by a mix of appropriations dollars and user fees.

“PhRMA has long backed the establishment of an approval pathway for biosimilars that is conducive to the thorough assessment of the safety and efficacy of these medicines. We look forward to participating in the FDA’s public meeting and continued work with the agency as it implements a regulatory pathway that ensures the safety, purity, and potency of biosimilar products.

“The performance goals letter published today demonstrates FDA’s commitment to a science-driven approach for biosimilars. The letter provides for FDA and sponsor meetings for the substantive review of biosimilar development plans. It also includes a special protocol assessment mechanism for clinical trials intended to establish biosimilarity and/or interchangeability with the innovator biologic product. This provision will help to ensure that clinical trials are designed to thoroughly assess the safety and efficacy of biosimilar medicines, in accordance with the FDA’s high regulatory and scientific standards.”