Japanese regulatory authority's perspective on biosimilars.
Office of New Drug V, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan; Division of Genetic Therapeutics, The Advanced Clinical Research Center, The Institute of Medical Science, The University of Tokyo, Tokyo 1088639, Japan. Electronic address: sunagai-tky@umin.ac.jp.
Sumimasa
S
Nagai
Office of Standards and Guidelines Development, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Reiko
R
Yanagihara
Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Yasuhiro
Y
Kishioka
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000592:standards* / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals