Literature DB >> 25752552

Japanese regulatory authority's perspective on biosimilars.

Sumimasa Nagai1, Reiko Yanagihara2, Yasuhiro Kishioka3.   

Abstract

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Year:  2015        PMID: 25752552     DOI: 10.1016/S1470-2045(14)71220-3

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


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  6 in total

Review 1.  Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices.

Authors:  Stella Stergiopoulos; Kenneth Getz
Journal:  Drug Saf       Date:  2015-08       Impact factor: 5.606

Review 2.  Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction.

Authors:  Ylenia Ingrasciotta; Paola M Cutroneo; Ilaria Marcianò; Thijs Giezen; Fabiola Atzeni; Gianluca Trifirò
Journal:  Drug Saf       Date:  2018-11       Impact factor: 5.606

Review 3.  The changing landscape of biosimilars in rheumatology.

Authors:  Thomas Dörner; Vibeke Strand; Paul Cornes; João Gonçalves; László Gulácsi; Jonathan Kay; Tore K Kvien; Josef Smolen; Yoshiya Tanaka; Gerd R Burmester
Journal:  Ann Rheum Dis       Date:  2016-03-08       Impact factor: 19.103

Review 4.  Totality of Scientific Evidence in the Development of ABP 980, a Biosimilar to Trastuzumab.

Authors:  Hans-Christian Kolberg; Marco Colleoni; Patricia Santi; Georgia Savva Demetriou; Miguel Angel Segui-Palmer; Yasuhiro Fujiwara; Sara A Hurvitz; Vladimir Hanes
Journal:  Target Oncol       Date:  2019-12       Impact factor: 4.493

5.  Efficacy and safety of a single switch from etanercept originator to etanercept biosimilar in a cohort of inflammatory arthritis.

Authors:  Maria Chiara Ditto; Simone Parisi; Marta Priora; Silvia Sanna; Clara Lisa Peroni; Angela Laganà; Antonio D'Avolio; Enrico Fusaro
Journal:  Sci Rep       Date:  2020-09-30       Impact factor: 4.379

Review 6.  The Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape: A Narrative Review of Current Evidence.

Authors:  Brian G Feagan; Mona Marabani; Jashin J Wu; Freddy Faccin; Claire Spronk; Gilberto Castañeda-Hernández
Journal:  Adv Ther       Date:  2020-09-10       Impact factor: 3.845

  6 in total

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