MYL1501D Insulin Glargine: A Review in Diabetes Mellitus
Compliance with Ethical Standards
Funding: The preparation of this review was not supported by any external funding.
Conflicts of interest: Sheridan Hoy is a salaried employee of Adis International Ltd/SpringerNature, is responsible for the article content and declares no relevant conflicts of interest.
Additional information about this Adis Drug Review can be found here.
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 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.