The Academy of Managed Care Pharmacy (AMCP) is writing to express concerns with specific provisions of House Bill 4472 regarding the regulation of biological products and the substitution of interchangeable biological products when dispensed by pharmacists. We strongly support the language in the Bill that allows a pharmacist to substitute an FDA approved “interchangeable biological product.”
The Academy of Managed Care Pharmacy (AMCP) thanks the International Society for Pharmacoeonomics and Outcomes Research (ISPOR) for the opportunity to comment on the Draft Special Task Force Report “A Health Economics Approach to US Value Assessment Frameworks” issued on May 4, 2017 as part of its Initiative on US Value Assessment Frameworks.
AMCP supports the implementation of a robust biosimilars pathway to ensure that Americans continue to receive access to safe, effective, and affordable biologics and biosimilars. AMCP has been working extensively with the Food and Drug Administration and other stakeholders on federal and state legislation and regulations that impact the biosimilars pathway.
The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to “Considerations in Demonstrating Interchangeability With a Reference Product: Guidance for Industry [Docket No. FDA-2017-D-0154]” as published in the Federal Register on January 18, 2017.
All of the undersigned groups share the FDA's deep commitment to the development of a robust biosimilars market for patients, and greatly appreciate all the work the agency has done in creating certainty around the approval pathway created by the Biologics Price Competition and Innovation Act (BPCIA), including the long anticipated proposed guidance detailing the requirements of obtaining an interchangeability designation for a biosimilar.