Interchangeable Insulins: FDA Holds Public Meeting

Regulatory NewsRegulatory News | 13 May 2019 |  By 

Although insulin biosimilars and interchangeable products will not hit the US market until March 2020 at the earliest, the US Food and Drug Administration (FDA) on Monday held a public meeting to hear from various companies and stakeholders on the standards for establishing interchangeability and what patient experience to consider.

Acting FDA Commissioner Ned Sharpless kicked off the meeting explaining how insulin competition is currently limited (only three follow-on insulin products—Basaglar, Lusduna and Admelog—have been approved since 2015) and how list prices have increased dramatically over the past decade.

But the issuance of final guidance Friday on what studies need to be conducted to establish interchangeability and earlier guidance on transitioning certain biologics previously regulated as drugs should help companies looking to bring insulin competitors to market.

Several of the industry and academic speakers also explained how patients currently switch between different insulin products, which raised the question of why there should be two distinct categories for insulin biosimilars and interchangeable insulins.

Others, such as Mylan’s head of global clinical research Abhijit Barve, stressed the need for streamlined approaches to developing interchangeable insulins.


But representatives of companies currently controlling a large slice of the insulin market in the US raised questions about interchangeability. For instance, Sherry Martin, VP of Eli Lilly, introduced the idea of an insulin “ecosystem,” perhaps as a way to try to stave off competition even longer.


Others, however, such as Jing Luo of Brigham and Women’s Hospital in Boston, stressed the need for interchangeable insulins, as cost-related insulin underuse is common, and is associated with worse clinical outcomes and death. He also explained how minor differences in efficacy between products may not be clinically significant.


Christine Simmon, executive director of the Biosimilars Council, also stressed that FDA should continue emphasizing that a transition from a reference product to a non-interchangeable biosimilar will not result in changes to safety or effectiveness.



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