Japanese regulatory authority's perspective on biosimilars - authors' reply
- PMID: 25752553
- PMCID: PMC5105594
- DOI: 10.1016/S1470-2045(15)70047-1
Japanese regulatory authority's perspective on biosimilars - authors' reply
Conflict of interest statement
We declare no competing interests.
Comment on
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Regulatory and clinical considerations for biosimilar oncology drugs.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.
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Japanese regulatory authority's perspective on biosimilars.Lancet Oncol. 2015 Mar;16(3):e101. doi: 10.1016/S1470-2045(14)71220-3. Lancet Oncol. 2015. PMID: 25752552 No abstract available.
References
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- Arato T, Yamaguchi T. Experience of reviewing the follow-on biologics including somatropin and erythropoietin in Japan. Biologicals. 2011;39:289–92. - PubMed
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- Yamaguchi T, Arato T. Quality, safety and efficacy of follow-on biologics in Japan. Biologicals. 2011;39:328–32. - PubMed
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- Nagasaki M, Ando Y. Clinical development and trial design of biosimilar products: a Japanese perspective. J Biopharm Stat. 2014;24:1165–72. - PubMed
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- 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)
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