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Regulatory Focus™ > News Articles > 2019 > 6 > Industry Groups Debate FDA’s Approach to Interchangeable Insulin Products

Industry Groups Debate FDA’s Approach to Interchangeable Insulin Products

Posted 05 June 2019 | By Michael Mezher 

Industry Groups Debate FDA’s Approach to Interchangeable Insulin Products

Branded and generic drugs industry groups are sparring over the US Food and Drug Administration’s (FDA) approach to regulating biosimilar and interchangeable insulin products following a public meeting on the matter last month.
In March 2020, FDA will begin transitioning certain biological products – such as insulin, insulin analogs and human growth hormone – that were initially approved under new drug applications (NDAs) to be deemed to be licensed under section 351 of the Public Health Service Act (PHS Act).
After the transition, the newly deemed insulin products can be used as reference products for biosimilar or interchangeable insulin products. In December, FDA issued two draft and two final guidances, as well as a proposed rule, aimed at clarifying its expectations for biosimilars and deemed to be licensed products.
In comments submitted to the public docket for the hearing, the Association for Accessible Medicines (AAM) says it believes FDA should better pave the way for interchangeable insulin products.
“Insulin is a ‘simpler’ molecule than other more complex biologics such as monoclonal antibodies and has been extensively characterized and significant real-world evidence related to the safety and efficacy of insulin exists,” AAM writes.
AAM also argues that interchangeability will have a greater impact on biosimilar insulin products compared to other products as insulin is dispensed at retail pharmacies where interchangeable products could be substituted by a pharmacist.
“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,” AAM writes, noting that immunogenicity is not a concern for insulins.
“FDA should give consideration to these aspects specific to the insulin market when evaluating an application for interchangeability,” AAM writes.
In its submission, the Biotechnology Innovation Organization (BIO) referred to its previous comments in response to the hearing notice and other recent guidances related to biological products and biosimilars.
But BIO emphasized that it believes biosimilar and interchangeable insulin products should be held to the same standards as other biosimilars.
“The FDA should apply the same principles it is applying to other biosimilar development programs as outlined in FDA’s published guidances to date that implement the BPCIA,” BIO writes.
Public Docket

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