(Review) Review of Biosimilar

Biosimilar needs to be comparable to an already approved biotechnology-derived drug product in regard to quality, safety and efficacy. This video explains the definition, manufacturing process, studies and assessment required for the approval.
・Guideline for Ensuring Quality, Safety, and Efficacy of Biosimilars February 4, 2020　PSEHD/PED Notification No. 0204-1:
www.pmda.go.jp...
・Questions and Answers (Q&A) on Guideline for Ensuring the Quality, Safety, and Efficacy of BiosimilarsJanuary 25, 2024、PSB/PED Administrative Notice:
www.pmda.go.jp...