AAM and Biosimilars Council Applaud FDA on Interchangeability Guidance
“AAM and the Biosimilars Council applauds the FDA’s timely guidance on interchangeability for biosimilars, particularly its streamlined data and study design requirements that allow flexibility and the use of global comparator products to support applications. While the interchangeability designation does not confer any additional quality or safety attributes for FDA-approved biosimilars, we look forward to continue working with the agency to bring biosimilar medicines to America’s patients.”
-Christine Simmon, Executive Director, Biosimilars Council
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.
AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. Additional information is available at www.accesiblemeds.org.