論生物相似性藥品上市審查規範：以美國生物藥品價格競爭與創新法為師或為鑒？

Abstract

2010年10月23日美國歐巴馬政府簽署公告「生物藥品價格競爭與創新法」，正式開始全球最大單一藥品市場對生物相似性藥品的明文規範。從專利或競爭的方面來看，生物相似性藥品類似於學名藥，因係參考原開發商一已獲准上市之特定生物藥品，故在生物相似性藥品上市前需要考量參考藥品是否有專利保護、原開發商是否被主管機關賦予一市場專屬或資料專屬的行政保護期間。但從技術的本質來看，生物相似性藥品跟學名藥截然不同，前者的結構遠較後者複雜，學名藥得以簡易上市之前提在於證明學名藥與特定（小分子）藥品相等，而現今的技術僅能證明生物相似性藥品與特定生物藥品相似。美國聯邦政府於2012年預算計畫中倡議「生物藥品價格競爭與創新法」所規定的市場專屬期間應縮短為7年以節省政府支出。2012年2月美國藥政主管機關依法公開生物相似性藥品相關指引後，生物藥品原開發商亞培旋即於4月表達其反對該法施行之立場及論據。隨著90年代上市的生物藥品相關專利將陸續到期，生物相似性藥品的上市審查法規成為各藥品開發商關注的焦點，本文認為美國「生物藥品價格競爭與創新法」誕生於其特定的環境，我國的相關規範除了呼應技術的本質及進展外，更應該與我國產業現況一致。

The President Obama of United States signed the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) into law on October 23rd, 2010, and initiated the official regulation of biosimilar by the largest single pharmaceutical market in the world. From the perspective of patent or competition, biosimilar is similar to generics, because it references to a specific approved product as well. Likewise, whether there is patent or exclusivity covered the reference product is an issue to be considered in approving a biosimilar. However, from the perspective of technical nature, biosimilar and generics are totally different, because the structures of biologics are so complicated that different products can only be proved similarity or comparability, but not sameness, which is the prerequisite of the abbreviated approach in approving generics. In the budget of the U.S. government for fiscal year 2012, Obama administration proposed to reduce the 12 years of exclusivity for biologics to 7 years to control governmental expenditure. After the U.S. Food and Drug Administration published relevant guidelines for Biosimilar, Abbott Laboratories, one of the innovators of biologics, opposed the execution of BPCI Act. As the patents covered the biologics launched in 90’s expiring, the regulation of biosimilar is gaining attention. This article advocates the BPCI Act was fostered in a particular American political environment which does not exist in Taiwan. The regulatory policy of Taiwan shall echo not only the evolving technical nature, but also the industrial circumstances faced by Taiwan.