10.6084/m9.figshare.11955207.v1 Sheridan M. Hoy Sheridan M. Hoy MYL1501D Insulin Glargine: A Review in Diabetes Mellitus Adis Journals 2020 MYL1501D insulin glargine 100 U/mL Semglee® Diabetes mellitus Review Adis Drug Evaluation 2020-03-25 20:36:57 Online resource https://adisjournals.figshare.com/articles/online_resource/MYL1501D_Insulin_Glargine_A_Review_in_Diabetes_Mellitus/11955207 <p>Compliance with Ethical Standards</p><p><i>Funding</i>: The preparation of this review was not supported by any external funding.</p><p><i>Conflicts of interest: </i>Sheridan Hoy is a salaried employee of Adis International Ltd/SpringerNature, is responsible for the article content and declares no relevant conflicts of interest.</p><p><br></p><p>Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews"><b>here</b></a>.<br></p><p><br></p><p>Abstract<br></p><p>Subcutaneous MYL1501D insulin glargine 100 U/mL (hereafter referred to as MYL1501D insulin glargine) [Semglee<sup>®</sup>] 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<sup>®</sup>] in various countries, including in the EU for the treatment of diabetes mellitus in patients aged ≥ 2 years and in 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 100 U/mL 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.<br></p><p><br></p><div>© Springer Nature Switzerland AG 2020<br></div>