Press Release

PhRMA Statement on Biosimilars Regulatory Pathway

PhRMA August 4, 2011

Washington, D.C. (August 4, 2011) —Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President David E. Wheadon today issued the following statement on the FDA’s ongoing efforts to develop a user fee program and regulatory pathway for biosimilars products:


“A perspective piece published today in The New England Journal of Medicine outlines important themes in the ongoing development of an effective and efficient review and approval process for biosimilars.


“We support the Food and Drug Administration’s efforts to implement the Biologics Price Competition and Innovation Act in an open and transparent manner through the development of a distinct user fee program and regulatory pathway, as directed by the legislation, supported by general and class-specific guidance and related regulation for biosimilars.


“Given the complexity of biologic molecules and the need to ensure that biosimilar products are as safe and effective as innovator biologics, well-designed studies employing state-of-the-art techniques to demonstrate biosimilarity should consist of a stepwise process that begins with molecular evaluations and ends with clinical trials. We agree with FDA that implementation of a robust, modern pharmacovigilance program for biosimilars is essential to ensure patient safety.


“Such a program must be funded through specific Congressional appropriations supplemented by user fees. It must not divert resources from the review of innovative new medicines and slow the availability of new treatments for unmet medical needs.


“We look forward to working with the Agency to ensure that the stand-alone user fee program and science-based regulatory pathway provide patient access to safe and effective biosimilar products, while fostering future innovation and competition.”


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