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).
AMCP CEO Blog: The White House made news last month with its blueprint to lower drug prices. But it's also important to note that biosimilars will play a crucial role in fostering competition and lowering costs.