MYL1501D Insulin Glargine: A Review in Diabetes Mellitus

Abstract

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.

Current utilization patterns for long-acting insulin analogues including biosimilars among selected Asian countries and the implications for the future

“…Biosimilar insulin glargine, the first long-acting insulin analogue biosimilar, has been shown to have similar effectiveness and safety to the originator in a number of studies including those conducted in Japan (68)(69)(70)(71)(72). However, there can be concerns with the extent of price reductions versus originators in practice as seen in the United Kingdom, which may impact on future use in practice (73)(74)(75)(76).…”

Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications

“…Biosimilars are a potential way forward to reduce the cost of long-acting insulin analogues building on the appreciable price reductions seen with biosimilars to treat rheumatoid arthritis [52][53][54][55][56]. In addition, a number of published studies have now demonstrated similar effectiveness and safety between the originator and biosimilar long-acting insulin analogues [57][58][59][60][61]. However, potential savings from biosimilar insulin glargine can be limited in practice, potentially accentuated by the dominance of three companies currently controlling 96% of the global insulin market by volume and 99% by value discouraging competition [36,46].…”

New Insulins, Biosimilars, and Insulin Therapy

“…Participants from INSTRIDE 1 who completed 52 weeks of reference insulin glargine treatment were randomized 1:1 to the reference sequence (n = 63; insulin glargine for 36 weeks) or to the treatment-switching sequence (n = 64; MYL-1501D [weeks 0-12], insulin glargine [weeks [12][13][14][15][16][17][18][19][20][21][22][23][24], MYL-1501D [weeks [24][25][26][27][28][29][30][31][32][33][34][35][36]). The primary efficacy endpoint used to show equivalence between the two treatment sequences was a change in HbA1c from baseline to week 36.…”

“…It took Mylan/Biocon quite a while to get this approval, at least in part due to a lawsuit Sanofi has filed against Mylan/ Biocon alleging infringement of its patents and also due to a number of quality issues with the insulin manufacturing plant that the FDA raised repeatedly to BioCon; these were solved NEW INSULINS, BIOSIMILARS, AND INSULIN THERAPY S-65 more recently (https://www.centerforbiosimilars.com/news/ biocons-malaysia-insulin-plant-is-okd-by-fda). The properties of MYL-1501D were presented in detail in a recent review of this drug (32). Semglee has already acquired approvals in more than 40 countries, including Europe, Australia, Japan, and South Korea, and is on the market in a number of these.…”