Japanese regulatory authority's perspective on biosimilars

Affiliations

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.

Comment

Sumimasa Nagai et al. Lancet Oncol. 2015 Mar.

. 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

Comment in

Japanese regulatory authority's perspective on biosimilars - authors' reply.
Bennett CL, Chen B, Hermanson T, Georgantopoulos P, Sartor OA. Bennett CL, et al. Lancet Oncol. 2015 Mar;16(3):e102. doi: 10.1016/S1470-2045(15)70047-1. Lancet Oncol. 2015. PMID: 25752553 Free PMC article. No abstract available.

Regulatory and clinical considerations for biosimilar oncology drugs.
Bennett CL, Chen B, Hermanson T, Wyatt MD, Schulz RM, Georgantopoulos P, Kessler S, Raisch DW, Qureshi ZP, Lu ZK, Love BL, Noxon V, Bobolts L, Armitage M, Bian J, Ray P, Ablin RJ, Hrushesky WJ, Macdougall IC, Sartor O, Armitage JO. Bennett CL, et al. Lancet Oncol. 2014 Dec;15(13):e594-e605. doi: 10.1016/S1470-2045(14)70365-1. Epub 2014 Nov 24. Lancet Oncol. 2014. PMID: 25456378 Free PMC article. Review.