Test your knowledge of biosimilar approvals in China.
Name 3 companies that have gotten biosimilars approved in China.
Biosimilars Regulatory Roundup for September 2023—Podcast Edition
October 1st 2023On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.
BioRationality: FDA Launches a New Opportunity to Remove Redundant Trials of Biosimilars
November 6th 2023The FDA introduced a plan to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.
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