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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Payers are watching whether FDA's evolving policy on designating insulins as biologics may inhibit competition from less expensive products and worry that innovator products could gain extended marketing exclusivity as part of the transition.

The government "is considering re-categorizing insulins as biologics, which could extend patent protection in a category that already is experiencing...

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