Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications-Reference-Cited by-同舟云学术

Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications

Published:2016-05-20 Issue:8 Volume:18 Page:737-746
ISSN:1462-8902
Container-title:Diabetes, Obesity and Metabolism
language:en
Short-container-title:Diabetes Obes Metab

Author:

Dowlat H. A.¹,Kuhlmann M. K.²,Khatami H.³,Ampudia-Blasco F. J.⁴

Affiliation:

1. PharmaBio Consulting; Freiburg Germany

2. Department of Internal Medicine-Nephrology; Vivantes Klinikum im Friedrichshain; Berlin Germany

3. Fortress Biotech; New York NY USA

4. Department of Endocrinology and Nutrition; Clinic University Hospital of Valencia; Valencia Spain

Funder

Sanofi

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/dom.12676/fullpdf

Reference44 articles.

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2. An overview of current regulatory requirements for approval of biosimilar insulins;Heinemann;Diabetes Technol Ther,2015

3. European Commission What you need to know about biosimilar medicinal products. Process on corporate responsibility in the field of pharmaceuticals access to medicines in Europe http://ec.europa.eu/DocsRoom/documents/8242/attachments/1/translations/en/renditions/native

4. Safer administration of insulin: summary of a safety report from the National Patient Safety Agency;Lamont;BMJ,2010

5. Insulin pens vs. vials and syringes: differences in clinical and economic outcomes;Bastian;Consult Pharm,2011

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