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

我们研究项目的目的是分析生物制品行业的竞争和政策。该研究将在产业组织中采用当前的实证技术来评估替代政策在塑造这一以科学为基础的产业的竞争性质方面的影响，并在引入生物仿制药（“非专利生物制剂”）对价格、数量、获取和消费者福利的实证影响方面发挥特别作用。为了进行这些研究，该项目将使用IMS最近获得的数据，包括涵盖美国和其他14个国家的产品、收入和数量数据。非美国的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创新政策选择，导致了生物仿制药的进入。在美国正在考虑对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政策选择的影响，这些国家已经制定了进入政策并已经进入。生物药物是公共和私人资助生物技术和生命科学研究的最重要的临床和商业成果之一。由于有机产品具有更大的结构复杂性，生物制品的生产过程要比化学药品复杂得多。必须开发源细胞系，细胞通常在特殊设计的培养基中生长，并以特定的方式过滤，并且每批产品可能有几个生产过程阶段。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。仿制生物制剂的进入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，而竞争本身取决于由基础生产技术驱动的差异化程度，以及决定专利条款和FDA专有权提供保护的监管规则。更广泛的影响：在经济学中，专注于理解生物制品市场的产业组织和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，以评估替代性准入法规和知识产权保护政策如何影响准入、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的份额越来越大）和政策环境，这一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，但大多数实质性政策决定都留给了FDA和其他监管机构来制定和实施。尽管这一政策辩论对竞争政策和医疗保健成本的重要性，但支持生物药物之间竞争的条件尚未被经济学家系统地研究过。这个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.