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Frequency of Approval and Marketing of Biosimilars with a Skinny Label and Associated Medicare Savings

Egilman AC, Van de Wiele VL, Rome BN, Darrow JJ, Tu SS, Kesselheim AS, Sarpatwari A - JAMA Internal Medicine

Research Publications

| January 2023

Innovation Incentives and Competition
Price, Value, and Access
Regulation and Clinical Evidence

Summary:

Between 2015 and 2021, 67% of biosimilars were approved with skinny labels, enabling earlier competition before all patents expired on the originator biologic expired. This pathway generated an estimated $1.5 billion in Medicare savings, highlight the value of this pathway amid increasing legal threats.

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