Vizient Says It Supports FDA Plan for Insulin Biosimilars, Interchangeable Insulins
The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.
Vizient said this week it endorses the FDA’s draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins.
The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.
In March, insulins will be regulated as biologics, and as such, developers will be able to seek licensure for subsequent-entry insulins under the biosimilar approval pathway after that time, whereas they are currently treated as follow-ons.
In a statement, Vizient said it believes FDA’s the guidance will support a more effective and efficient approval process by streamlining clinical data requirements.
“Vizient fully supports scientifically justified opportunities to improve approval processes for biosimilars and interchangeable biologics, including insulins,” Steven Lucio, Vizient’s vice president, pharmacy solutions, said in a statement.
“The approval of more insulin biosimilars will enable patients with diabetes to have much needed access to more affordable treatment options,” he added; the change will create more competion and lower healthcare spending.
In its comment on the draft, Vizient wrote that the FDA's approach is justified "given the strength of analytical characterization data, the less complex structure of insulin, and the absence of a clinical impact of immunogenicity with insulin use."
