AAM’s Biosimilars Council Applauds FDA’s Draft Guidance on Interchangeable Insulin

Tuesday January 28, 2020

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of the Association for Accessible Medicines (AAM), submitted comments to the Food and Drug Administration (FDA) draft guidance, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products,” applauding the agency for streamlining requirements for approval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and other groups bolstered AAM and the Council’s position noting, “We believe finalizing the policy outlined in the draft guidance will help speed the availability of automatically substitutable biosimilar insulin to America’s patients, thereby increasing competition and promoting more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.”

The Biosimilars Council looks forward to continuing to work closely with stakeholders, including the FDA, to increase patient access to critical and live-saving treatments.


About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 22 percent of total drug spending. Additional information is available at www.accessiblemeds.org.

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