AAM & Biosimilars Council Response to Pfizer Citizen Petition
The Association for Accessible Medicines (“AAM”), and its Biosimilars Council (“Council”) (collectively referred to in these comments as AAM), are pleased to submit comments in support of the Citizen Petition (“CP”) requesting that the FDA issue guidance to ensure truthful and non-misleading communications by reference product sponsors concerning the safety and effectiveness of biosimilars, including interchangeable biologics, relative to reference product(s), as submitted to the Agency by Pfizer on August 22, 2018.
AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic and biosimilar industry. The Council, a division of AAM, works to ensure a positive regulatory, reimbursement, political and policy environment for biosimilar products, and educate stakeholders and patients about the safety and effectiveness of biosimilars. Member organizations include companies and stakeholder organizations working to develop biosimilar products with the intent to participate in the U.S. market.
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.