Guidance Would Speed Availability of Automatically Substitutable Insulin to America’s Patients
WASHINGTON, DC (JANUARY 28, 2020) – The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), submitted comments to the Food and Drug Administration (FDA) draft guidance, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products,” applauding the agency for streamlining requirements for approval of biosimilar and interchangeable insulin based on sound science.
Today, patients face high prices and a lack of insulin therapy choices due to brand drug company rebates to payers, patent shenanigans and regulatory hurdles. Greater competition from biosimilar insulins offers the promise of significant savings and increased access for diabetes patients, and the FDA’s guidance is a key step toward that goal.
“The insulin market in the U.S. shares many of the challenges facing all biosimilars,” says Christine Simmon, Executive Director, Biosimilars Council, and Senior Vice President of Policy and Strategic Alliances, AAM. “We commend the FDA for demonstrating its commitment to increasing access to safe and effective alternatives to costly brand-name insulin treatments for patients, and support extending the guidance’s science-based flexibility around certain study requirements to biosimilars development and approval broadly.”
A letter to FDA Commissioner Ned Sharpless signed by 20 patient, consumer, taxpayer, employer, pharmacy, provider, health plan and other groups bolstered AAM and the Council’s position noting, “We believe finalizing the policy outlined in the draft guidance will help speed the availability of automatically substitutable biosimilar insulin to America’s patients, thereby increasing competition and promoting more affordable access through lower prices and out-of-pocket costs.”