Biosimilar insulins: guidance for data interpretation by clinicians and users

Author:

Heinemann L.1,Home P. D.2,Hompesch M.3

Affiliation:

1. Science & Co Düsseldorf Germany

2. Institute of Cellular Medicine ‐ Diabetes, The Medical School Newcastle University Newcastle upon Tyne UK

3. Profil Institute for Clinical Research San Diego CA USA

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

Reference35 articles.

1. Eli Lilly and Company.European Commission grants Lilly and Boehringer Ingelheim's insulin glargine product marketing authorisation in Europe.2014. Available from URL:www.lilly.mediaroom.com/index.php?s=9042&item=137348. Accessed 31 December 2014.

2. European Medicines Agency.EPAR summary for the public Abrasia insulin glargine.2014. Available from URL:ema.europa.eu/docs/en_GB/document_library/EPAR_‐_Public_assessment_report/human/002835/WC500175383.pdf. Accessed 31 December 2014.

3. An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins

4. Opportunities and Challenges for Biosimilars: What's on the Horizon in the Global Insulin Market?

5. IMS Health.Shaping the biosimilars opportunity.2011. Available from URL:www.imshealth.com/ims/Global/Content/Home%20Page%20Content/IMS%20News/Biosimilars_Whitepaper.pdf. Accessed 31 December 2014.

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4. Pharmacokinetic and Pharmacodynamic Assessment of Novel and Biosimilar Insulins;Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease;2019

5. SAR342434 - an insulin biosimilar for the treatment of type II diabetes;Expert Opinion on Biological Therapy;2018-10-10

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