Development Considerations for Biosimilar Insulin Delivery Devices

Companies developing biosimilar insulins are entering a crowded marketplace where the device used to deliver the biosimilar insulin can have a substantial impact on patient preference.
“Biosimilar” insulin delivery devices should not fundamentally differ from “originator” devices to preserve safety features and dosing accuracy, but there is substantial space to customize insulin devices for target populations.
Device development can take a variety of approaches from designing a novel product in house to licensing an existing product for use, but regardless of the route taken all new devices are subject to the same regulatory requirements, including clinical and user testing.