AAM submits comments at FDA public hearing on insulin biosimilars

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AAM submits comments at FDA public hearing on insulin biosimilars

By Sandra Levy - 05/20/2019
The Association for Accessible Medicines and the Biosimilars Council praised the Food and Drug Administration for today’s hearing, “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products.”

Speaking at the hearing, Cristine Simmon, executive director of the Biosimilars Council, and senior vice president of policy and strategic alliances, said, “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.

Simmon went on to say, “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.”

Simmon said that 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,” she said.

Simmon also pointed out that six of the most highly-utilized brand-name insulins increased in list price by more than 500% from 2006 to 2015. “Because patient cost-sharing is often based on the list price, before rebates or discounts, increases in list price directly impact a patient’s ability to afford their medicines and can cause increased patient abandonment and lower adherence,” she said.

“We applaud the FDA’s recent efforts in this space to ensure insulin biosimilars are able to efficiently be developed and come to market post-March 2020. We support the agency’s timely guidance on
interchangeability, particularly its streamlined data and study design requirements that allow flexibility and the use of global comparator products to support applications. While the interchangeability designation does not confer any additional quality or safety attributes for approved biosimilars, the statutory requirement under BPCIA makes the designation necessary for automatic substitution at the retail pharmacy. Interchangeability will be particularly important in the insulin space," Simmon said.

Simmon noted that significant evidence exists that a physician-led transition from a reference product to a noninterchangeable biosimilar does not result in a loss of safety or efficacy. "In the insulin space, brand-to-brand switches across insulin types occur frequently at the direction of the provider, and, given the highly similar nature of a biosimilar to its reference product, the risk of diminished safety or efficacy from a transition is minimal or not present."

Finally, the AAM summarized its position, stating:

  • The DA has significant experience with insulin and “highly similar” regulatory standard and should apply that experience to biosimilar insulin development;

  • The FDA should continue to highlight for stakeholders that interchangeability does not confer quality but is a statutory standard for automatic substitution at the pharmacy; and

  • The FDA should continue emphasizing that a transition from a reference product to a noninterchangeable biosimilar will not result in changes to safety or effectiveness.

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