FDA slams window on China-only data

FDA and its Oncologic Drugs Advisory Committee have slammed the window on U.S. approvals of “me-too” drugs developed entirely or mainly in China. The agency’s position casts a cloud over strategies to disrupt U.S. pricing by developing drugs in China with mechanisms of action similar to those approved in the U.S. and selling them to U.S. patients at a discount.

FDA stated that it was making an example of the BLA for Tyvyt sintilimab from Innovent Biologics Inc. (HKEX:1801) and Eli Lilly and Co. (NYSE:LLY) in order to deter applications from a pipeline of other PD-1s with China-only data. ...