Economic issues with follow-on protein products
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Updated: Jul 3, 2026

Mass Spectrometric Approaches to Study Protein Structure and Interactions in Lyophilized Powders
Published on: April 14, 2015
Michael Lanthier1, Rachel Behrman, Clark Nardinelli
1US Food and Drug Administration, Rockville, Maryland 20857, USA. michael.lanthier@fda.hhs.gov
Abstract:
The economic effects of the possible introduction of 'follow-on' protein products have been the subject of recent debate. Here, we aim to explore the economic issues surrounding this debate using three measures: total sales, product complexity and patent expiry. Our analysis shows that the sales of therapeutic protein products are concentrated in a relatively small number of branded products, which may be the most attractive targets for follow-on development. For the years 2013-2015, we estimate that products representing US$20 billion in annual sales--approximately half of all sales in 2006--can be expected to lose patent protection.
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