FDA pushes for development of biosimilar and interchangeable insulin

Noting it is aware that the high cost of insulin raises serious concerns about the ability of many patients to access insulin products, the US Food and Drug Administration yesterday announced new draft guidance that is intended to help facilitate the development of, and improve patient access to, life-saving insulin products, “ Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.

“The FDA is committed to continuing our efforts to help increase market competition among insulin products, which may potentially lower costs for patients and payors and increase access and product choice. This includes facilitating the development of safe and effective insulin products for the treatment of patients with type 1 and type 2 diabetes, including products that are biosimilar to, or interchangeable with, an approved insulin product,” the agency stated.

This draft guidance is intended to help guide efficient product development by clarifying what data and information may – or may not – be needed to support a demonstration of biosimilarity or interchangeability for a proposed insulin product, as defined in the draft guidance. The draft guidance reflects, among other things, the FDA’s decades of experience with insulin products which, along with wide clinical use, has contributed to a robust scientific understanding of these products. The draft guidance also reflects consideration of stakeholder feedback provided at the FDA’s  May 2019 public hearing on this topic at which stakeholders were invited to provide input on developing biosimilar and interchangeable insulin products.