Request that the FDA issue guidance to ensure truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars, including interchangeable biologics, relative to reference product(s).

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. Please find our full comments attached.