Scholars Award: The sciences of the similar: Innovations in chemistry and the limits of equivalence

仿制药被认为是名牌药的生化复制品，已成为当代科学创新和政策的重要组成部分。随着非专利替代品市场的增长——从1960年仅占美国制药市场的10%到2010年的近80%——关于非专利药是否真的与名牌药“等同”的技术和政治冲突也在增加。事实上，仿制药永远不会与它们的原药完全相同；相反，它们作为通用产品的身份在于，它们在监管机构和科学家认为重要的特定方面具有相似性。这个学者奖由STS项目和数学与物理科学理事会资助，将支持杰里米·格林，一位接受过人种学训练的内科历史学家，他追踪了20世纪末和21世纪初生化等效的科学和政策定义的出现。利用档案数据、科学出版物分析和深度访谈，格林将追踪“两种药物何时相同？”这个问题是如何根据提问的方法和学科而产生不同的答案的。例如，人们（在不同的时代和不同的国家）利用化学、生物、工程和管理科学方面的创新来论证或质疑仿制药的相似性。这项研究将有助于科学政策和法规的社会科学研究，以及科学和创新的历史。对不同时期和不同国家如何定义仿制药的仔细研究揭示了不同利益相关者如何促进和竞争定义生化等效的各种方法。解决等价性和互换性的问题也证明了专业化如何塑造科学知识的普遍性，以及有助于制定科学政策的文化和科学假设。

Generic pharmaceuticals are considered biochemical copies of brand-name drugs and have become an important component of contemporary scientific innovation and policy. As the market for generic substitutes has grown--from only 10% of the American pharmaceutical market in 1960 to nearly 80% by 2010--so too have technical and political conflicts over whether generics are truly "the same thing" as their brand-name counterparts. Indeed, generic drugs are never fully identical to their original counterparts; rather, their identity as generic resides in being similar in the particular ways that regulators and scientists think matter. This Scholar's Award, funded by the STS program and the Directorate for Mathematical and Physical Sciences, will support Jeremy Greene, a physician-historian with ethnographic training, as he tracks the emergence of scientific and policy definitions of biochemical equivalence in the late 20th century and early 21st century. Using archival data, analysis of scientific publications, and in-depth interviews, Greene will trace how the question: "when are two medicines the same?" generates different answers depending on the method and discipline from which it is asked. For example, people (at different times and in different countries) have used innovations in chemistry, biology, engineering, and management science to either argue for or contest the similarity of generic pharmaceuticals. This research will contribute to social scientific studies of science policy and regulation as well as the history of science and innovation. A close examination of how generics are defined over time and across countries reveals how different stakeholders promote and contest various ways of defining biochemical equivalence. Grappling with the problems of equivalence and interchangeability also demonstrates how specialization shapes the generalizability of scientific knowledge and the cultural and scientific assumptions that help produce science policy.