U.S. Biosimilar Market Entry Challenges and Facilitating Factors

There is ongoing interest in understanding ways to reduce drug prices and improve patient access to prescription drugs in the U.S. The estimated savings to the U.S. healthcare system from the use of biosimilars are significant. However, there is limited research on the cost of biosimilar development, expected market uptake for biosimilar entrants, barriers that may affect market entry decisions, and potential incentives to encourage market entry. This study aims to fill these gaps by evaluating potential biosimilar development policy changes. Using public and proprietary data sources combined with insights from subject matter experts, this report finds: 

• Market size and entry order significantly influence the revenues of an average biosimilar throughout its market life. The net revenue over the first biosimilar’s lifetime ranges from -$33.5 million in small markets to $9.5 billion in large markets.
• Designating all approved biosimilars as interchangeable could increase lifetime net revenue by $2 billion.
• Establishing a global comparator would streamline the biosimilar development process and result in cost savings ($5.1 million), and increased lifetime net revenue ($13.5 million).
• Eliminating the requirement for comparative efficacy studies could lead to cost savings amounting to $24 million and increase lifetime net revenue by $84 million.

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  https://aspe.hhs.gov/reports/competition-biologics