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.
