Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin 70/30 with <scp>US</scp> ‐licensed HUMULIN® 70/30 formulation in healthy subjects: Results from the <scp>RHINE</scp> ‐3 ( R ecombinant H uman <scp> IN sulin </scp> E quivalence‐3) study-Reference-Cited by-同舟云学术

Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin 70/30 with US ‐licensed HUMULIN® 70/30 formulation in healthy subjects: Results from the RHINE ‐3 ( R ecombinant H uman IN sulin E quivalence‐3) study

Published:2022-06-06 Issue:9 Volume:24 Page:1819-1828
ISSN:1462-8902
Container-title:Diabetes, Obesity and Metabolism
language:en
Short-container-title:Diabetes Obesity Metabolism

Author:

Plum‐Mörschel Leona¹,Klein Oliver²,Singh Gursharan³^ORCID,Murugesan Sundara Moorthi Nainar³,Marwah Ashwani³,Sharma Nirant³,Panda Jayanti³,Loganathan Subramanian³,Lakshmi Gopu Chandrasekharan³,Athalye Sandeep N.³

Affiliation:

1. Profil Mainz Germany

2. Profil Neuss Germany

3. Biocon Biologics Ltd. Bengaluru India

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/dom.14768

Reference35 articles.

1. LaMattinaJ.Human insulin is available for as little as $24.88—but it's not for everyone. Forbes Magazine; 2021.https://www.forbes.com/sites/johnlamattina/2020/01/30/human-insulin-is-available-for-as-little-as-2488but-its-not-for-everyone/?sh=6ae2e46e5c48. Accessed February 16 2022.

2. U.S. Food and Drug Administration.Clinical pharmacology data to support a demonstration of biosimilarity to a reference product: guidance for industry; 2016.https://www.fda.gov/media/88622/download. Accessed December 12 2021.

3. U.S. Food and Drug Administration.Clinical immunogenicity considerations for biosimilar and interchangeable insulin products: guidance for industry; 2019.https://www.fda.gov/media/133014/download. Accessed February 15 2022.

4. Addressing Insulin Access and Affordability: An Endocrine Society Position Statement

5. Basal Plus Basal–Bolus Approach in Type 2 Diabetes

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