Literature DB >> 25752553

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

Charles L Bennett1, Brian Chen2, Terhi Hermanson3, Peter Georgantopoulos4, Oliver A Sartor5.   

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Year:  2015        PMID： 25752553      PMCID： PMC5105594          DOI： 10.1016/S1470-2045(15)70047-1

Source DB:  PubMed          Journal:  Lancet Oncol        ISSN： 1470-2045            Impact factor:   41.316


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  4 in total

Review 1.  Quality, safety and efficacy of follow-on biologics in Japan.

Authors:  Teruhide Yamaguchi; Teruyo Arato
Journal:  Biologicals       Date:  2011-09-03       Impact factor: 1.856

Review 2.  Regulatory and clinical considerations for biosimilar oncology drugs.

Authors:  Charles L Bennett; Brian Chen; Terhi Hermanson; Michael D Wyatt; Richard M Schulz; Peter Georgantopoulos; Samuel Kessler; Dennis W Raisch; Zaina P Qureshi; Z Kevin Lu; Bryan L Love; Virginia Noxon; Laura Bobolts; Melissa Armitage; John Bian; Paul Ray; Richard J Ablin; William J Hrushesky; Iain C Macdougall; Oliver Sartor; James O Armitage
Journal:  Lancet Oncol       Date:  2014-11-24       Impact factor: 41.316

3.  Clinical development and trial design of biosimilar products: a Japanese perspective.

Authors:  Masayuki Nagasaki; Yuki Ando
Journal:  J Biopharm Stat       Date:  2014       Impact factor: 1.051

Review 4.  Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan.

Authors:  Teruyo Arato; Teruhide Yamaguchi
Journal:  Biologicals       Date:  2011-09-13       Impact factor: 1.856
  4 in total

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