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Comment
. 2015 Mar;16(3):e102.
doi: 10.1016/S1470-2045(15)70047-1.

Japanese regulatory authority's perspective on biosimilars - authors' reply

Affiliations
Comment

Japanese regulatory authority's perspective on biosimilars - authors' reply

Charles L Bennett et al. Lancet Oncol. 2015 Mar.
No abstract available

PubMed Disclaimer

Conflict of interest statement

We declare no competing interests.

Comment on

  • 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.
  • Japanese regulatory authority's perspective on biosimilars.
    Nagai S, Yanagihara R, Kishioka Y. Nagai S, et al. Lancet Oncol. 2015 Mar;16(3):e101. doi: 10.1016/S1470-2045(14)71220-3. Lancet Oncol. 2015. PMID: 25752552 No abstract available.

References

    1. Bennett CL, Chen B, Hermanson T, et al. Regulatory and clinical considerations for biosimilar oncology drugs. Lancet Oncol. 2014;15:e594–605. - PMC - PubMed
    1. Arato T, Yamaguchi T. Experience of reviewing the follow-on biologics including somatropin and erythropoietin in Japan. Biologicals. 2011;39:289–92. - PubMed
    1. Yamaguchi T, Arato T. Quality, safety and efficacy of follow-on biologics in Japan. Biologicals. 2011;39:328–32. - PubMed
    1. Nagasaki M, Ando Y. Clinical development and trial design of biosimilar products: a Japanese perspective. J Biopharm Stat. 2014;24:1165–72. - PubMed
    1. Arato T. Recent regulations of biosimilars in Japan. The Drug Information Association Conference; Chicago, Illinois, USA. Jun 19–23, 2011; http://www.pmda.go.jp/regulatory/file/english_presentation/biologics/B-E... (accessed Oct 15, 2014)

MeSH terms

Substances