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Economic issues with follow-on protein products
Michael Lanthier1, Rachel Behrman, Clark Nardinelli
1US Food and Drug Administration, Rockville, Maryland 20857, USA. michael.lanthier@fda.hhs.gov
Nature Reviews. Drug Discovery
|July 26, 2008
Summary
Follow-on protein products may target high-sales biologic drugs losing patent protection. This analysis estimates $20 billion in annual sales from biologics will face patent expiry between 2013-2015.
Area of Science:
- Biotechnology
- Pharmaceutical Economics
- Intellectual Property Law
Background:
- The economic impact of introducing 'follow-on' protein products, also known as biosimilars, is a significant area of recent debate within the pharmaceutical industry.
- Understanding these economic effects is crucial for stakeholders, including manufacturers, healthcare providers, and patients, as biosimilars have the potential to increase market competition and reduce healthcare costs.
Approach:
- This study examines the economic landscape of therapeutic protein products by analyzing three key metrics: total sales revenue, product complexity, and patent expiry dates.
- The analysis focuses on identifying which branded biologic products are most likely to be targeted for follow-on development based on their market performance and patent status.
Key Points:
- Sales of therapeutic protein products are highly concentrated, with a small number of blockbuster drugs accounting for a substantial portion of the market.
- A significant number of high-revenue biologic products are projected to lose patent protection in the near future.
- Specifically, products generating approximately $20 billion in annual sales (representing about half of the 2006 market value) are expected to face patent expiry between 2013 and 2015.
Conclusions:
- The concentration of sales in a few key products suggests these will be prime candidates for follow-on protein product development.
- The impending patent expiries for major biologic drugs present a substantial opportunity for the introduction of follow-on products, potentially altering market dynamics.
- This economic analysis provides critical insights into the market potential and strategic considerations for follow-on protein product development and market entry.
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