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FDA Is Urged To Make All Biosimilar Insulins Interchangeable

 
• By Dave Wallace

As part of feedback on the future of insulin biosimilars in the wake of FDA guidance over transitioning insulins to biologic status, the agency has been urged to deem all biosimilar insulins interchangeable as well as to push back against originator attempts to shield individual product ‘ecosystems’ from competition.

Insulin
The Agency Is Evaluating Input On Insulins • Source: Shutterstock

Demonstrating biosimilarity for insulin products in the US “should automatically generate an interchangeability designation”, according to comments submitted to the US Food and Drug Administration by Biocon as part of a consultation revolving around increasing access to and facilitating development of biosimilar and interchangeable insulins.

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