Biosimilar Interchangeability and Substitution in the US: What Comes Next?

Rome BN, Bhaskar A, Kesselheim AS - American Journal of Managed Care

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

Summary:

FDA regulatory changes that allow more biosimilars to be deemed interchangeable with their reference product are important steps to improve access to biosimilars. However, other policy changes are needed to boost biosimilar competition in the US, including adjusting state laws to more easily permit automatic pharmacist substitution of biosimilars, reforms to pharmacy benefit manager practices, and better clinician and patient education.

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