AAM and Biosimilars Council Remarks at FDA Biosimilars Public Hearing on Insulin

Monday May 13, 2019

Christine Simmon, Executive Director, Biosimilars Council, and Senior Vice President of Policy and Strategic Alliances, AAM spoke at the Food and Drug Administration’s (FDA) public hearing, “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products.”


Thank you for the opportunity to speak at today’s Part 15 Hearing on considerations for biosimilar and interchangeable insulin. We look forward to responding in more detail to the FDA’s posed questions in our submission to the docket.

As former FDA Commissioner Gottlieb noted, regulating insulin under the Public Health Service Act will allow for more efficient development of biosimilar and interchangeable insulin for America’s 7.5 million diabetes patients that rely on insulin to manage their disease, a population that has doubled in the past two decades.

As we have seen in the biosimilars space to date, competition works to bring down monopoly prices for costly biologics. Marketed biosimilars are currently, on average, discounted 47% below their respective reference products list price and 18% lower in terms of net price (ASP) in Medicare Part B.

And as Congress has noted, competition is sorely needed in the insulin space. We look forward to working with the Agency and policymakers to achieve this goal. The insulin market in the U.S. is a direct reflection of issues facing biosimilar broadly. The current insulin market lacks significant competition to the detriment of patient access and health and has been characterized as a public health crisis. The combination of regulatory challenges, over-patenting to stave off competition, and anti-competitive rebating and contracting tactics by brand firms has been the cause of the lack of competition.

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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 23 percent of total drug spending. Additional information is available at www.accesiblemeds.org.

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