Japanese regulatory authority's perspective on biosimilars

Lancet Oncol. 2015 Mar;16(3):e101. doi: 10.1016/S1470-2045(14)71220-3.

¹ 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.
² Office of Standards and Guidelines Development, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
³ Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

No abstract available

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