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Interchangeable Insulins Could Be Left Out Of Diabetes Treatment ‘Ecosystem’

 
• By Sue Sutter

US FDA assessment of proposed biosimilar and interchangeable insulins in existing delivery forms should be separate from a future determination of whether the products can be safely used as part of a digitally connected treatment system, Lilly says. FDA, AAM representatives suggest this ecosystem approach could become a barrier to access for follow-on products.

Diabetes Flat Icon Set - Insulin Pump, Glucometer, Syringe, Injection Pen, Lancets, Blood Glucose Test COPYRIGHT: Shutterstock: HelgaMariah
Lilly wants the FDA to conduct a separate interchangeability assessment when insulin is used as part of a connected system. • Source: Shutterstock

The biosimilarity and interchangeability assessment for insulins in existing presentations should be separate from the determination of whether such products can be safely used as part of a digitally connected diabetes treatment “ecosystem,” insulin maker Eli Lilly & Co. told the US Food and Drug Administration on 13 May.

In comments at an FDA public hearing, Lilly urged the agency to limit its near-term assessment of follow-on insulins to their use in existing

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