生物相似性藥品不同於以往化學學名藥,在本質與研發上需要較高技術與資金門檻,基於產業前景可期,值得我國生技業者積極投入。但在決定投入該產業前必須先評估各項風險,其中最重要者在於目標市場的上市規範。本文針對我國生技業者最可能進入的目標市場:美國、臺灣及中國大陸三者,介紹並分析各國的現行上市規範,作為我國生技業者投資之參考。 由於2010年美國通過實施Patient Protection and Affordable Care Act將原有的Biologics Price Competition and Innovation Act納入其中,修定生物相似性藥品之簡要上市規範,相關制度建置完善值得我國與中國大陸參考。基此,本文就生物相似性藥品上市相關法規範議題討論係以美國為主要參考範本,綜合考量臺灣與中國大陸之產業現況,提出相關建議。 本文以前述兩大方向為主軸撰寫,透過文獻分析的方式介紹美國、臺灣及中國大陸之生物相似性藥品上市規範,並進一步討論相關的法規範議題,透過美國修法的角度重新檢視臺灣與中國大陸的現行制度。一方面提供我國生技製藥業者參考依據,另一方面也提供我國相關主管機關制度上的建議。
Biosimilars are different from chemical generics in many ways, especially in nature and development that biosimilars need higher technology and more capital from research to manufacture. Because of the future of biosimilar industry, it still worths biopharmaceutical industries in Taiwan to invest. But they have to estimate every risks before the decision to invest. Among those risks, the most important is the approval regulateons of the target markets. This article focus on the three possible target markets , which are U.S., Taiwan and Mainland China, introduces and analyzes the approval regulateons in order to help biopharmaceutical industries in Taiwan. On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act which included Biologics Price Competition and Innovation Act (Biosimilar Act). The Biosimilar Act sets up the complete framework of abbreviate biosimilar applications which worths Taiwan and Mainland China to reconsider their current legal framework in biosimilar. Based on the reason, this article will consider the current biopharmaceutical industry and the U.S. Biosimilar Act to give suggestions on relative issues. Based on these two main purposes, this article will introduce the current legal framework on biosimilar approvl regulateons by citation analysis, discuss relative legal issues, and reconsider the current legal framework on biosimilar in Taiwan and Mainland China through U.S. Biosimilar Act in order to help biopharmaceutical industries in Taiwan and give some suggestions for government in Taiwan.