title: Economic issues with follow-on protein products.
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.
authors.affiliation: US Food and Drug Administration, Rockville, Maryland 20857, USA. michael.lanthier@fda.hhs.gov
authors.forename: Michael
authors.initials: M
authors.lastname: Lanthier
authors.forename: Rachel
authors.initials: R
authors.lastname: Behrman
authors.forename: Clark
authors.initials: C
authors.lastname: Nardinelli
mesh_terms: D001709:Biotechnology / Q000379:methods; D003132:Commerce; D017277:Drug Approval / Q000191:economics / Q000379:methods; D006801:Humans; D010330:Patents as Topic; D011506:Proteins / Q000191:economics* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D011506:Proteins