Provision in Spending Bill Paves Way for Follow-On Insulins

December 20, 2019

Biosimilars Team

As reported by BioWorld, a single sentence “buried more than 1,500 pages into a fiscal 2020 spending bill” passed by the U.S. Senate on Thursday is set to expand the definition of a “biological product” to include chemically synthesized polypeptides. Specifically, the bill amends Section 351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) by striking the phrase “(except any chemically synthesized polypeptide)”.

FDA Deputy Commissioner for Policy, Legislation, and International Affairs Anna Abram and Center for Drug Evaluation and Research Director Janet Woodcock, MD, released a statement earlier this week voicing support for the change. They noted that most protein products that were approved as drug products (including every insulin currently on the market) will open up to biosimilar and interchangeable competition in March 2020. Under the existing language, chemically synthesized polypeptides are excluded from this transition; if a developer were to chemically synthesize a copy of a protein product (e.g., an insulin copy), the copy would have to be approved via a resource-intensive new drug application. Removing the exclusion provides the potential for chemically synthesized follow-on insulins and other protein products to come to market through more efficient abbreviated pathways. It also will help to promote potential innovation in manufacturing methods, which could lead to future efficiencies in manufacturing processes.