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

我们的研究计划的目标是分析生物制品行业的竞争和政策。该研究将采用当前产业组织的实证技术，评估替代政策对塑造这一以科学为基础的行业竞争性质的影响，特别是对引入生物仿制药（“通用生物制剂”）对价格、数量、获取和消费者福利的实证影响。为了进行这些研究，该项目将使用最近从IMS获得的数据，包括美国和其他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;虽然美国的竞争主要集中在基于创新的竞争上，但一些欧洲国家已经做出了导致生物仿制药进入的创新政策选择。在美国正在考虑生物仿制药的替代政策选择的环境中，该项目能够检查几个欧洲国家的政策选择的影响，这些国家已经制定了入境政策并已进入。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的最重要的临床和商业后果之一。由于有机产品的结构更复杂，生物制品的制造过程比化学药物复杂得多。必须开发源细胞系，细胞通常在专门设计的培养基中生长，并以特定方式过滤，并且每批产品的生产过程可能有几个阶段。产品和制造过程的复杂性，以及产品市场的具体方面，为产业组织提出了新的问题。生物仿制药进入美国市场的成本和收益是一个非常重要的问题：进入美国市场的成本将取决于FDA的法规以及生产细节，而收益将取决于产品之间竞争的影响，而竞争本身取决于基础生产技术驱动的差异化程度以及决定专利条款和FDA排他性提供的保护的监管规则。更广泛的影响：在经济学领域，关注了解生物制品市场的产业组织以及替代监管方法对生物制品行业的影响的研究相对较少。该项目将提供基础数据和分析，以评估替代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（生物制剂在数量和收入中所占份额越来越大）和政策环境，该主题越来越具有政策相关性。制定促进生物类似药进入途径的规则是PPACA的一部分，但大多数实质性政策决定都留给FDA和其他监管机构制定和实施。尽管这一政策辩论对竞争政策和医疗保健成本具有重要意义，但经济学家尚未系统地研究支持生物药物竞争的条件。该项目将填补这一空白。

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.