Duration of action of two insulin glargine products, LY2963016 insulin glargine and Lantus insulin glargine, in subjects with type 1 diabetes mellitus-Reference-Cited by-同舟云学术

Duration of action of two insulin glargine products, LY2963016 insulin glargine and Lantus insulin glargine, in subjects with type 1 diabetes mellitus

Published:2016-09-08 Issue:1 Volume:19 Page:33-39
ISSN:1462-8902
Container-title:Diabetes, Obesity and Metabolism
language:en
Short-container-title:Diabetes Obes Metab

Author:

Linnebjerg Helle¹,Lam Eric Chen Quin²,Zhang Xin¹,Seger Mary E.¹,Coutant David¹,Chua Laiyi²,Kapitza Christoph³,Heise Tim³

Affiliation:

1. Eli Lilly and Company; Indianapolis Indiana

2. Lilly-NUS Centre for Clinical Pharmacology; Singapore Singapore

3. Profil; Neuss Germany

Funder

Eli Lilly and Company

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/dom.12759/fullpdf

Reference20 articles.

1. ® https://products.sanofi.us/lantus/lantus.html

2. Eli Lilly and Company European Commission grants Lilly and Boehringer Ingelheim's insulin glargine product marketing authorisation in Europe 2014 http://investor.lilly.com/releasedetail.cfm?ReleaseID=870088

3. European Medicines Agency Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues 2015 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500184161.pdf

4. US Food and Drug Administration Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry 2015 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf

5. US Food and Drug Administration Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference protein product. Guidance for industry 2015 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf

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