Working With Policy Makers to Effectively Implement Biosimilars

Policy Considerations and Future Directions

Key Themes:

• Incentive Alignment: Policy should make biosimilar adoption both easy and rewarding, ensuring financial incentives exist for all stakeholders involved in the transition.
• Interchangeability Regulations: Policy makers control interchangeability rules, which significantly impact implementation barriers and adoption rates.
• Innovation Funding: Biosimilar savings enable investment in next-generation innovations such as cell and gene therapies by freeing health care resources.

Key Points for Physicians:

• Medicare and Medicaid reimbursement policies significantly influence biosimilar adoption incentives.
• The Inflation Reduction Act includes provisions increasing biosimilar reimbursement, though additional adjustments may be needed.
• Patent litigation delays create uncertainty in biosimilar availability timelines, suggesting potential policy interventions.

Notable Insights:

Implementing biosimilars represents an opportunity for health care organizations to demonstrate good stewardship of limited health care resources while maintaining quality care.

Clinical Significance: Policy interventions that streamline interchangeability, align stakeholder incentives, and address patent litigation delays can accelerate biosimilar adoption, ultimately enabling investment in next-generation therapies while maintaining sustainable health care costs.