Interchangeable Insulins — New Pathways for Safe, Effective, Affordable Diabetes Therapy

This perspective discusses the FDA’s draft guidance to streamline the approval of biosimilar insulin products by eliminating the requirement for clinical immunogenicity tests if the products are proven "highly similar" to reference insulins. The authors argue that insulin’s small molecular size, long history of safe use, and the urgent need for affordable diabetes treatment justify treating biosimilarity as sufficient proof of interchangeability. They highlight how current regulatory hurdles under the Biologics Price Competition and Innovation Act (BPCIA) have limited competition and kept insulin prices high. The proposed policy could lower costs and improve access for millions of Americans with diabetes, as real world insulin switching has not shown clinical risks. The authors emphasize that the benefits of affordable insulin outweigh theoretical concerns about immunogenicity.

This perspective discusses the FDA’s draft guidance to streamline the approval of biosimilar insulin products by eliminating the requirement for clinical immunogenicity tests if the products are proven "highly similar" to reference insulins. The authors argue that insulin’s small molecular size, long history of safe use, and the urgent need for affordable diabetes treatment justify treating biosimilarity as sufficient proof of interchangeability. They highlight how current regulatory hurdles under the Biologics Price Competition and Innovation Act (BPCIA) have limited competition and kept insulin prices high. The proposed policy could lower costs and improve access for millions of Americans with diabetes, as real world insulin switching has not shown clinical risks. The authors emphasize that the benefits of affordable insulin outweigh theoretical concerns about immunogenicity.