AMCP CEO Statement on FDA’s Proposed Guidance That Would Reclassify Insulin as a Biologic

Alexandria, Va., Dec. 11, 2018 — Academy of Managed Care Pharmacy (AMCP) CEO Susan A. Cantrell, RPh, CAE, issued a statement on the Food and Drug Administration’s release today of various proposed guidances on biologics and biosimilars, including one that would reclassify insulin as a biologic:

“Nearly 30 million Americans have diabetes, many of them requiring insulin to manage their disease. Access to insulin can mean life or death, and it can keep patients out of the hospital and in better health. AMCP applauds FDA Commissioner Scott Gottlieb’s plan to reclassify insulin as a biologic by 2020, which would allow for biosimilar substitution that can contain the cost of treatment and create space to drive innovation; we thank him for providing additional clarity for this transition. Our members are strong supporters of biosimilars and reducing barriers to them. While the new guidances released today provide some more clarity on the scientific and regulatory processes for biosimilars, we urge the agency to re-issue guidance soon on interchangeability to support broader adoption of biosimilars in the US. If pharmacists remain unable to switch a reference product with its biosimilar, the promise of biosimilars will not be fully realized.”

Read the guidances: Read Gottlieb’s statement: