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Demonstrating Value for Biosimilars: A Conceptual Framework
Sotiris Rompas1, Thomas Goss2, Sally Amanuel3
1Director, Boston Healthcare Associates, MA.
American Health & Drug Benefits
|June 19, 2015
Summary
Biosimilar value extends beyond cost savings, requiring a framework that addresses diverse stakeholder needs. Understanding these needs is crucial for successful development, commercialization, and adoption of biosimilars.
Area of Science:
- Pharmacoeconomics
- Health Services Research
- Drug Development
Background:
- Biosimilar value proposition extends beyond cost reduction to encompass diverse stakeholder needs.
- Successful transition from clinical development to market requires a comprehensive framework.
Purpose of the Study:
- Identify factors influencing biosimilar development, commercialization, and adoption.
- Recommend program design modifications to demonstrate biosimilar value to payers, providers, and patients.
Main Methods:
- Surveys with payers and clinicians in the US and EU5 markets.
- International protocol feasibility assessments.
- Literature review on patient perceptions of generics to inform biosimilar hypotheses.
Main Results:
- Conflicting and convergent demands exist for biosimilar data collection.
- Motivations and data requirements vary among stakeholders.
- Regulatory, economic, and clinical incentives need careful consideration.
Conclusions:
- Biosimilar development is an international endeavor with potential challenges and opportunities.
- Evolving regulatory guidance and stakeholder sentiments shape development and positioning.
- Program design must align with payer, physician, and patient needs for successful market entry.
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