Insulin glargine is a long-acting basal insulin analogue given once daily to help control blood glucose levels in people with diabetes. It consists of microcrystals that slowly release insulin, providing a duration of action of 18 to 26 hours. Insulin glargine is indicated for diabetes mellitus in adults, adolescents, and children aged two years and above. The originator product is Sanofi’s Lantus (insulin glargine) [1].

Langlara (insulin glargine-aldy) is a once-daily, long-acting basal insulin glargine with approximately 24-hour, relatively peakless activity. Manufactured by Sunshine Lake Pharma (Dongguan, Guangdong Province, China) and commercialized in the US by Lanexa Biologics. It is indicated to improve glycaemic control in adult and paediatric patients with diabetes mellitus. Because it is an interchangeable biosimilar, pharmacists may substitute Langlara for Lantus without a new prescriber prescription, subject to state laws [2].

Langlara (insulin glargine-aldy) is available as a 100 units/mL injection for subcutaneous use in a 3 mL single-patient-use prefilled pen, biosimilar to and interchangeable with US-Lantus (insulin glargine) 100 units/mL SoloStar prefilled pen.

The FDA approval was based on a comprehensive analytical, preclinical, and clinical programme. According to Lannett Company, Inc (parent of Lanexa Biologics), the data package confirmed the pharmacokinetic/ pharmacodynamic profiles, efficacy, safety, and immunogenicity of Langlara as comparable to Lantus in patients with both type 1 and type 2 diabetes.

The June 2024 FDA draft guidance reduced reliance on dedicated switching studies, allowing justification from existing comparative data – a change that has accelerated interchangeable biosimilar determinations [3].

The approval includes a license for Sunshine Lake Pharma to manufacture the insulin glargine-aldy at its YiChang HEC ChangJiang Pharmaceutical Co Ltd facility in Yidu, Hubei Province, China. With this approval, Sunshine Lake Pharma becomes the first Chinese pharmaceutical company to receive FDA approval for an insulin product in the US.

Before Langlara’s approval, the FDA had cleared two other interchangeable insulin glargine biosimilars: Eli Lilly’s Rezvoglar (insulin glargine-aglr) and Biocon’s Semglee (insulin glargine-yfgn), both approved in 2021.

The entry of a third interchangeable biosimilar insulin glargine is expected to further intensify competition in the insulin market, potentially lowering costs and expanding patient access to this critical class of diabetes therapies. 

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of insulin glargine [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jun 5]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
2. GaBI Online - Generics and Biosimilars Initiative. What is the future for the US biosimilar interchangeability designation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jun 5]. Available from: www.gabionline.net/biosimilars/research/what-is-the-future-for-the-us-biosimilar-interchangeability-designation
3. GaBI Online - Generics and Biosimilars Initiative. FDA interchangeable biosimilars guidance update on revised approach to switching studies [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jun 5]. Available from: www.gabionline.net/guidelines/fda-interchangeable-biosimilars-guidance-update-on-revised-approach-to-switching-studies

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