Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022

Kuribayashi, R; Nakano, A; Hariu, A; Kishioka, Y; Honda, F

Kuribayashi, R (通讯作者),Pharmaceut & Med Devices Agcy, Off Cellular & Tissue Based Prod, 3-3-2 Kasumigaseki,Chiyoda Ku, Tokyo 1000013, Japan.

BIODRUGS, 2023; 37 (4): 443

Abstract

A biosimilar product is defined as a biological product that is highly similar to an existing, approved biological product (known as originator or ref......

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