Lanthier Michael, Behrman Rachel, Nardinelli Clark
US Food and Drug Administration, Rockville, Maryland 20857, USA.
Nat Rev Drug Discov. 2008 Sep;7(9):733-7. doi: 10.1038/nrd2636.
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.
“后续”蛋白质产品的可能引入所产生的经济影响一直是近期争论的焦点。在此,我们旨在通过三项指标来探究围绕这一争论的经济问题:总销售额、产品复杂性和专利到期情况。我们的分析表明,治疗性蛋白质产品的销售集中在相对较少的品牌产品上,这些产品可能是后续开发最具吸引力的目标。对于2013 - 2015年,我们估计年销售额达200亿美元(约占2006年总销售额的一半)的产品有望失去专利保护。