Comparative study of the number of report and time-to-onset of the reported adverse event between the biosimilars and the originator of filgrastim-Reference-Cited by-同舟云学术

Comparative study of the number of report and time-to-onset of the reported adverse event between the biosimilars and the originator of filgrastim

Published:2017-06-14 Issue:8 Volume:26 Page:917-924
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Kobayashi Tetsu¹^ORCID,Kamada Izumi²,Komura Junko³,Toyoshima Satoshi²,Ishii-Watabe Akiko¹

Affiliation:

1. Division of Biological Chemistry and Biologicals; National Institute of Health Sciences; Tokyo Japan

2. Faculty of Pharmacy; Musashino University; Tokyo Japan

3. Office of Safety I; Pharmaceuticals and Medical Devices Agency; Tokyo Japan

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference37 articles.

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2. EU's new pharmacovigilance legislation: considerations for biosimilars;Calvo;Drug Saf,2014

3. Clinical safety of biosimilar recombinant human granulocyte colony-stimulating factors;Abraham;Expert Opin Drug Saf,2013

4. Annex 1 summary of product characteristics http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000917/WC500046525.pdf

5. European public assessment reports http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124&source=homeMedSearch&keyword=filgrastim&category=human&isNewQuery=true

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