The Association for Accessible Medicines and the Biosimilars Council (collectively referred to as “AAM”) are pleased to provide comments on the Food and Drug Administration’s (“FDA’s” or the “Agency’s”) Question and Answer guidance documents regarding biosimilar development under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).
AAM is submitting consolidated comments that address both FDA’s draft guidance entitled New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (“Draft Q&A Guidance”) and FDA’s final guidance entitled Questions and Answers on Biosimilar Development and the BPCI Act (“Final Q&A Guidance”). AAM represents the manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry. Generics represent greater than 90% of all prescriptions dispensed in the U.S. by volume, but only 23% of the cost expended on prescription drugs. AAM is the sole association representing America’s generic pharmaceutical sector in the United States. The Council, a division of AAM, works to ensure a positive regulatory, reimbursement, political and policy environment for biosimilar products, and educates the public and patients about the safety and effectiveness of biosimilars. Areas of biosimilar focus include education, access, the nascent regulatory environment, reimbursement and legal issues. Member organizations include companies and stakeholder organizations working to develop biosimilar products with the intent to participate in the U.S. market.