Abstract
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.