Similar pharmacokinetics and pharmacodynamics of rapid-acting insulin lispro products SAR342434 and US- and EU-approved Humalog in subjects with type 1 diabetes

Author:

Kapitza Christoph1ORCID,Nowotny Irene2,Lehmann Anne2,Bergmann Karin2,Rotthaeuser Baerbel2,Nosek Leszek1,Becker Reinhard H. A.2

Affiliation:

1. Profil; Neuss Germany

2. Sanofi-Aventis Deutschland GmbH; Frankfurt Am Main Germany

Funder

Sanofi

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

Reference8 articles.

1. Opportunities and challenges for biosimilars: what's on the horizon in the global insulin market?;Rotenstein;Clin Diabetes,2012

2. 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

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

4. Insulin glulisine, a new rapid-acting insulin analogue, displays a rapid time-action profile in obese non-diabetic subjects;Becker;Exp Clin Endocrinol Diabetes,2005

5. Recommendations guiding physicians in biomedical research involving human subjects;World Medical Association Declaration of Helsinki;JAMA,1997

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