Insulin Market Competition: Payers Watching FDA 'Transition' Policy
FDA policies around the upcoming regulatory reclassification of insulins as biologics may impact payers' ability to leverage competition and pricing in the market, Express Scripts suggests.
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Draft order wants "comprehensive review" to find regulations that that "unnecessarily increases expenses" for patients, researchers, and manufacturers.
Industry objects to proposal that certain protein product applications pending as of March 23, 2020, will have to be resubmitted as BLAs – and to the idea that transitioned products will lose non-orphan exclusivity.
As FDA gears up to turn some NDAs into BLAs, insulins may have the most to lose – or gain, if the agency changes its approach.