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Biosimilars and the European experience: implications for the United States
Health Affairs (Project Hope)
|October 9, 2013
Summary
Lower-cost biosimilars are expected to reduce healthcare expenses. The US market may develop into two tiers: non-interchangeable and interchangeable biosimilars, with the latter offering greater cost savings.
Area of Science:
- Pharmaceutical Economics
- Drug Regulation
- Biotechnology
Background:
- Biologics are high-cost medications derived from biological sources.
- Patent expirations on originator biologics create opportunities for lower-cost alternatives.
- Biosimilars offer potential for significant healthcare cost reduction.
Purpose of the Study:
- To analyze the potential impact of biosimilars on the US pharmaceutical market.
- To explore the anticipated market dynamics following FDA approval of biosimilars.
- To forecast cost-saving potentials of biosimilars in the US.
Main Methods:
- Review of European Union biosimilar market data and regulatory frameworks.
- Analysis of projected cost savings based on market penetration.
- Forecasting of US market structure based on regulatory pathways.
Main Results:
- Biosimilars have been available in the EU since 2006, with substantial projected savings.
- The US Food and Drug Administration (FDA) has not yet finalized biosimilar approval processes.
- The US market is predicted to become bimodal, with non-interchangeable and interchangeable categories.
Conclusions:
- The introduction of biosimilars is anticipated to lower healthcare costs.
- A bimodal US market is expected, with varying levels of discounts.
- Interchangeable biosimilars may offer more significant price reductions than non-interchangeable ones.
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