In June 2020, Semglee became the first biosimilar of Sanofi’s Lantus (insulin glargine) to receive approval from the US Food and Drug Administration (FDA) both the vial and pen presentations of an insulin glargine treatment [1]. With an identical amino acid sequence, Semglee is a biosimilar of Lantus and has been approved for the same indications. However, due to the approval pathway taken, it does not have official biosimilar status in the US. After submitting all relevant documentation, those at Mylan are hopeful that Semglee will be approved as a biosimilar to Lantus under the 351(k) pathway and receive an interchangeability designation. This would make it the first biosimilar to receive an interchangeability designation allowing pharmacists to fill prescriptions with biosimilars without consulting the prescriber. Having this designation is likely to speed up the uptake of Semglee.

The Semglee (insulin glargine injection) vial and pre-filled pen presentations have been approved to help control high blood sugar in adult and child patients with type 1 diabetes and adults with type 2 diabetes. Insulin glargine is a long-acting basal insulin analogue, administered once a day, it consists of microcrystals that slowly release insulin, acting over a period of 18 to 26 hours. Its use is not recommended for the treatment of diabetic ketoacidosis.

To improve patient access to Semglee, it is now available in vial and pen presentations at a 65% discounted list price. With wholesale acquisition cost (WAC) of US$147.98 per package of five 3 mL pens and US$98.65 per 10 mL vial, these are the lowest prices available for long-acting insulin glargine products on the market. They are equivalent to the prices charged by Sanofi for the pen and vial in 2007 and 2010, respectively. With limited competition, the price of a Lantus vial almost doubled from US$244 in 2013, to US$431 in 2019.

It is hoped that these low prices will encourage patient uptake and expand access to this treatment option for the over 30 million diabetes patients in the US. In addition, eligible patients may also qualify for patient assistance and/or a co-pay card, which would further improve their access to this treatment option.

Kiran Mazumdar-Shaw, Executive Chairperson at Biocon said, ‘Leveraging our science and global scale manufacturing expertise, we have been expanding affordable access to biosimilar insulins to patients in Japan, Australia, Europe, India and key emerging markets. The US launch of Semglee takes us closer to realizing our aspiration of reaching ‘one in five’ insulin dependent people with diabetes worldwide’.

Semglee approval was based on comprehensive analytical, preclinical and clinical studies which confirmed the pharmacokinetic (PK)/pharmacodynamic (PD), efficacy, safety profile and immunogenicity of Semglee as compared to Lantus. Following these rigorous comparisons with the reference in participants with both type 1 and 2 diabetes, the lead investigator for the clinical trials, Dr Thomas Blevins, said ‘Semglee yielded similar (non-inferior) glycemic results in both groups. The safety, including immunogenicity, was similar too’.

Semglee has also been approved as a biosimilar in Europe in 2018 [2] and is now approved in over 45 countries worldwide. It joins two other Mylan/Biocon products to receive US FDA approval [3].

Semglee has the potential to be a large competitor in the insulin glargine market. The patent for Sanofi’s Lantus originator product expired in 2014 and prior to the advent of biosimilars in 2015, Lantus generated an estimated US$6.4 billion in net sales income for Sanofi [4]. More recently, Sanofi’s total IQVIA sales for the 12 months ending 30 June 2020 were approximately US$1.64 billion for the Lantus 100 Units/mL vial and US$$4.36 billion for the Lantus SoloSTAR pen.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves insulin glargine biosimilar Semglee [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 18]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-insulin-glargine-biosimilar-Semglee 
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the Europe  [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 18]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 18]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US 
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of insulin glargine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 18]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-insulin-glargine 

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