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物的生化复制品，已成为当代科学创新和政策的重要组成部分。随着仿制药替代品市场的增长--从1960年仅占美国制药市场的10%到2010年的近80%--仿制药是否真的与品牌药“一样”的技术和政治冲突也在增长。事实上，仿制药从来都不是完全相同的原始对应物;相反，它们作为仿制药的身份在于监管机构和科学家认为重要的特定方式的相似性。这个学者奖，由STS计划和数学和物理科学理事会资助，将支持杰里米格林，一个具有人种学培训的医生历史学家，因为他跟踪出现的科学和政策定义的生化等价性在20世纪世纪末和21世纪初世纪。利用档案数据、科学出版物的分析和深入访谈，格林将追踪“两种药物在什么时候是相同的？“会根据提问的方法和学科产生不同的答案。例如，人们（在不同的时间和不同的国家）使用化学，生物学，工程学和管理科学的创新来争论或质疑仿制药的相似性。这一研究将有助于科学政策和监管的社会科学研究，以及科学和创新的历史。对仿制药如何随着时间的推移和国家之间的定义的仔细检查揭示了不同的利益相关者如何促进和竞争定义生化等效性的各种方式。解决等效性和可解释性问题还表明，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.