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MYL1501D Insulin Glargine: A Review in Diabetes Mellitus
Subcutaneous MYL1501D insulin glargine 100 U/mL (hereafter referred to as MYL1501D insulin glargine) [Semglee(®)] is a long-acting human insulin analogue approved as a biosimilar of insulin glargine 100 U/mL (hereafter referred to as reference insulin glargine 100 U/mL) [Lantus(®)] in various countr...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer International Publishing
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7217807/ https://www.ncbi.nlm.nih.gov/pubmed/32215829 http://dx.doi.org/10.1007/s40259-020-00418-x |
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author | Hoy, Sheridan M. |
author_facet | Hoy, Sheridan M. |
author_sort | Hoy, Sheridan M. |
collection | PubMed |
description | Subcutaneous MYL1501D insulin glargine 100 U/mL (hereafter referred to as MYL1501D insulin glargine) [Semglee(®)] is a long-acting human insulin analogue approved as a biosimilar of insulin glargine 100 U/mL (hereafter referred to as reference insulin glargine 100 U/mL) [Lantus(®)] in various countries, including those of the EU for the treatment of diabetes mellitus in patients aged ≥ 2 years, as well as Japan for diabetes where insulin therapy is indicated. MYL1501D insulin glargine has similar physicochemical characteristics and biological properties to those of EU- and US-sourced reference insulin glargine 100 U/mL, with the bioequivalence of pharmacodynamic and pharmacokinetic parameters between these agents shown in adults with type 1 diabetes. Once-daily MYL1501D insulin glargine demonstrated noninferior glycaemic efficacy to that of once-daily reference insulin glargine 100 U/mL in adults with type 1 or 2 diabetes, with its glycated haemoglobin-lowering benefits maintained over the longer-term (52 weeks) and unaffected by previous insulin exposure. Switching between MYL1501D insulin glargine and reference insulin glargine 100 U/mL did not appear to impact glycaemic efficacy in adults with type 1 diabetes. MYL1501D insulin glargine was well tolerated, demonstrating a safety and immunogenicity profile similar to that of reference insulin glargine 100 U/mL in patients with type 1 and 2 diabetes, and in those with type 1 diabetes switching between the two agents. As expected, hypoglycaemia was the most frequently reported treatment-emergent adverse event. Thus, MYL1501D insulin glargine provides an effective biosimilar alternative for patients requiring insulin glargine therapy. |
format | Online Article Text |
id | pubmed-7217807 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-72178072020-05-14 MYL1501D Insulin Glargine: A Review in Diabetes Mellitus Hoy, Sheridan M. BioDrugs Adis Drug Evaluation Subcutaneous MYL1501D insulin glargine 100 U/mL (hereafter referred to as MYL1501D insulin glargine) [Semglee(®)] is a long-acting human insulin analogue approved as a biosimilar of insulin glargine 100 U/mL (hereafter referred to as reference insulin glargine 100 U/mL) [Lantus(®)] in various countries, including those of the EU for the treatment of diabetes mellitus in patients aged ≥ 2 years, as well as Japan for diabetes where insulin therapy is indicated. MYL1501D insulin glargine has similar physicochemical characteristics and biological properties to those of EU- and US-sourced reference insulin glargine 100 U/mL, with the bioequivalence of pharmacodynamic and pharmacokinetic parameters between these agents shown in adults with type 1 diabetes. Once-daily MYL1501D insulin glargine demonstrated noninferior glycaemic efficacy to that of once-daily reference insulin glargine 100 U/mL in adults with type 1 or 2 diabetes, with its glycated haemoglobin-lowering benefits maintained over the longer-term (52 weeks) and unaffected by previous insulin exposure. Switching between MYL1501D insulin glargine and reference insulin glargine 100 U/mL did not appear to impact glycaemic efficacy in adults with type 1 diabetes. MYL1501D insulin glargine was well tolerated, demonstrating a safety and immunogenicity profile similar to that of reference insulin glargine 100 U/mL in patients with type 1 and 2 diabetes, and in those with type 1 diabetes switching between the two agents. As expected, hypoglycaemia was the most frequently reported treatment-emergent adverse event. Thus, MYL1501D insulin glargine provides an effective biosimilar alternative for patients requiring insulin glargine therapy. Springer International Publishing 2020-03-25 2020 /pmc/articles/PMC7217807/ /pubmed/32215829 http://dx.doi.org/10.1007/s40259-020-00418-x Text en © Springer Nature 2020, corrected publication 2020 Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Adis Drug Evaluation Hoy, Sheridan M. MYL1501D Insulin Glargine: A Review in Diabetes Mellitus |
title | MYL1501D Insulin Glargine: A Review in Diabetes Mellitus |
title_full | MYL1501D Insulin Glargine: A Review in Diabetes Mellitus |
title_fullStr | MYL1501D Insulin Glargine: A Review in Diabetes Mellitus |
title_full_unstemmed | MYL1501D Insulin Glargine: A Review in Diabetes Mellitus |
title_short | MYL1501D Insulin Glargine: A Review in Diabetes Mellitus |
title_sort | myl1501d insulin glargine: a review in diabetes mellitus |
topic | Adis Drug Evaluation |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7217807/ https://www.ncbi.nlm.nih.gov/pubmed/32215829 http://dx.doi.org/10.1007/s40259-020-00418-x |
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