The Industrial Organization of the Biologics Industry: Theory, Empirics and Policy

生物制品行业的产业组织：理论、经验和政策

• 批准号: 1064341
• 负责人: Scott Stern
• 金额: $ 21.37万
• 依托单位: National Bureau of Economic Research Inc
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-15 至 2017-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1064341&HistoricalAwards=false
• 关键词: Industrial; Organization; Biologics; Industry; Theory

The objective of our research program is to analyze competition and policy in the biologics industry. The research will employ current empirical techniques in industrial organization to evaluate the impact of alternative policies in shaping the nature of competition in this science-based industry, with a particular role on the empirical impact of the introduction of biosimilars ("generic biologics") on price, quantity, access, and consumer welfare. To undertake these studies, the project will use recently-acquired data from IMS that includes product, revenue, and quantity data covering both the United States and 14 other countries. Non-US data is particularly important for evaluating entry and competition in this industry; while competition in the United States has been focused primarily on innovation-based competition, several European countries have made innovation policy choices that have resulted in the entry of biosimilars. In an environment where alternative policy choices towards biosimilars are under consideration within the US, this project is able to examine the impact of policy choices in several European countries where entry policies have been developed and entry has occurred. Biologic drugs are one of the most consequential clinical and commercial consequences of public and private research funding of biotechnology and life sciences research. Because of the greater structural complexity of organic products, the manufacturing process for biologic products is much more complicated than that for chemical drugs. The source cell line must be developed, the cells are typically grown in a specially-designed medium, and filtered in particular ways, and there may be several stages of production process for each batch of the product. The complexity of the products and the manufacturing process, as well as specific aspects of the product markets, raises new questions for industrial organization. The cost and benefit of entry by generic biologics is one very important issue: entry costs in the US will depend on FDA regulations as well as the details of manufacturing, while benefits will depend on the impact of competition among products, which itself depends on the degree of differentiation driven by underlying production technology and the regulatory rules that determine the protection provided by patent terms and FDA exclusivity. Broader impacts:There is relatively little research within economics focused on understanding the industrial organization of biologics product markets and the impact of alternative regulatory approaches for the biologics industry. The project will provide the foundational data and analysis to allow evaluation of how alternative entry regulations and intellectual property protection policies impact entry, competition, and consumer welfare. This topic is increasingly policy-relevant due to expenditure trends (an increasing share of both quantities and revenues are realized by biologics) and policy environment. The development of rules for facilitating a pathway for biosimilar entry is part of the PPACA, but most of the substantive policy decisions have been left as a matter for the FDA and other regulatory agencies to develop and implement. Despite the importance of this policy debate for competition policy and the cost of healthcare, the conditions supporting competition among biologic drugs has not been systematically studied by economists. This project will fill that gap.

我们研究计划的目的是分析生物制剂行业的竞争和政策。这项研究将采用工业组织中当前的经验技术来评估替代政策在塑造这一基于科学的行业中竞争性质的影响，并在引入生物仿制药（“通用生物学”）对价格，数量，访问权限和消费者福利的经验影响中发挥了特殊作用。为了进行这些研究，该项目将使用IMS最近获得的数据，其中包括涵盖美国和14个国家的产品，收入和数量数据。非美国数据对于评估该行业的进入和竞争尤为重要；尽管美国的竞争主要集中在基于创新的竞争上，但一些欧洲国家做出了创新政策选择，导致了生物仿制药的进入。在美国在美国正在考虑的替代政策选择的环境中，该项目能够检查一些欧洲国家的政策选择的影响，这些国家已经制定了进入政策并进行了进入。生物药物是生物技术和生命科学研究的公共和私人研究资金最结果的临床和商业后果之一。由于有机产品的结构复杂性更大，因此生物制品的制造过程比化学药品要复杂得多。必须开发源细胞系，通常以特殊设计的培养基生长，并以特定的方式过滤，并且每批产品可能存在几个生产过程阶段。产品的复杂性和制造过程以及产品市场的特定方面为工业组织提出了新的问题。通用生物制剂进入的成本和收益是一个非常重要的问题：美国的进入成本将取决于FDA法规以及制造的细节，而收益将取决于产品之间的竞争影响，这本身取决于基本生产技术和监管规则所驱动的分化程度，这些规则由专利条款和FDA提供了保护。更广泛的影响：经济学中的研究相对较少，重点是了解生物制品市场的工业组织以及替代监管方法对生物制度行业的影响。该项目将提供基础数据和分析，以评估替代性进入法规和知识产权保护政策如何影响进入，竞争和消费者福利。由于支出趋势（数量和收入的份额越来越多，生物制剂都会实现）和政策环境，因此该主题越来越与政策相关。制定促进生物仿制药进入途径的规则是PPACA的一部分，但是大多数实质性政策决策都是FDA和其他监管机构开发和实施的。尽管这项政策辩论对于竞争政策和医疗保健成本很重要，但经济学家尚未系统地研究生物药物之间竞争的条件。这个项目将填补这一空白。