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Insulin Market Competition: Payers Watching FDA 'Transition' Policy

Executive Summary

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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While industry awaits formal guidance ahead of March 2020 transition deadline for certain protein products, FDA's Christl says plan will take into account therapeutic equivalence ratings when deciding whether products are 'deemed' licensed as full biologic applications or biosimilars.

Biologics Transition Plan From US FDA Will Consider Therapeutic Equivalence Ratings

While industry awaits formal guidance ahead of March 2020 transition deadline for certain protein products, FDA's Christl says plan will take into account therapeutic equivalence ratings when deciding whether products are 'deemed' licensed as full biologic applications or biosimilars.

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