Biosimilar interchangeability and substitution in the US: what comes next?

Area of Science:

• Health Policy
• Pharmaceutical Economics
• Regulatory Science

Background:

• The Biologics Price Competition and Innovation Act of 2009 aimed to foster competition for biologic drugs.
• High spending on biologic medications necessitates strategies to control costs.
• Current U.S. Food and Drug Administration (FDA) interchangeability standards present a barrier to biosimilar adoption.

Purpose of the Study:

• To review the history and current status of biosimilar regulation in the United States.
• To evaluate the impact of FDA interchangeability standards on biosimilar competition.
• To identify policy recommendations for improving biosimilar market access and affordability.

Main Methods:

• Analysis of U.S. biosimilar regulatory history and current policies.
• Review of FDA interchangeability requirements and their implications.
• Examination of potential policy interventions beyond FDA standards.

Main Results:

• Modifying FDA interchangeability standards alone is unlikely to significantly enhance biosimilar competition.
• Payers, pharmacy benefit managers, and state laws influence biosimilar adoption.
• Education for clinicians and patients is crucial for building confidence in biosimilars.

Conclusions:

• Policy reforms are necessary to overcome barriers to biosimilar competition in the U.S.
• Broader strategies including state-level substitution laws and payer practices are essential.
• Expanding Medicare price negotiation could further improve biologic drug affordability.