China has just 9 biosimilars approved vs 29 in the United States, and the United States is expected to stay ahead in this race through 2027. However, fundamental regulatory reforms in China have established a framework for biosimilar development and approval that will encourage robust competition in that market, according to a recent presentation by intellectual property (IP) lawyers from Goodwin. In 2015, China created a standardized regulation for the development and evaluation of biosimilars, which Life Sciences associate Freddy Yip and IP Litigation partner Huiya Wu described as key to the biosimilars regulatory revolution in China. Read The Center for Biosimilars article here.
In The Press January 25, 2021