AMCP CEO Blog: AMCP’s roughly 8,000 members work diligently every day to improve patient care through the optimized use of medicines. As an organization, we also take a leading role in developing improvements to the overall delivery of care, which is no easy task given the size and complexity of our health care system.
Press Release: From News&Views April 2019: The Biologics Price Competition and Innovation Act (BPCIA) of 2009 created an FDA approval pathway for biosimilars that aimed to expanded patient access to these more affordable therapies.
On Dec 12, 2018, FDA issued a new proposal to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition Act of 2009 (BPCI Act). The BPCI Act amended the definition of biological product to include a “protein (except any chemically synthesized polypeptide.” To clarify these terms, FDA is proposing to provide its interpretation of the terms “protein” and “chemically synthesized polypeptide" to reduce regulatory uncertainty over what products are regulated as drugs or biological products.
On September 21, 2018, AMCP offered comments to the FDA on facilitating biosimilar adoption and the interchangeability designation. Comments focused on interchangeability guidance, naming conventions, and collection of post-marketing real-world evidence by partnering with organizations such as Biologics and Biosimilars Collective Intelligence Consortium (BBCIC).