On 4 May 2026, Lannett Company, with its wholly owned subsidiary, Lanexa Biologics, and Sunshine Lake Pharma (the pharmaceutical business arm of HEC Group) announced that the FDA has approved Langlara™ (insulin glargine-aldy), as an interchangeable biosimilar to Sanofi’s Lantus® (insulin glargine) for the treatment of certain adult and paediatric patients with diabetes.
Under a 2021 agreement, Sunshine Lake Pharma is responsible for manufacturing and supplying Langlara™, while Lanexa Biologics has the exclusive commercialisation rights in the US. Langlara™ is Lanexa’s first insulin product, although it reportedly has a short acting insulin aspart under development.
In July 2025, Aurobindo Pharma agreed to acquire Lannett, with the US$250M transaction scheduled to take up to 12 months to complete. Upon close of the acquisition, Lanexa will become a stand-alone company.
Biocon’s Semglee® was the first biosimilar approved in the United States as interchangeable to Sanofi’s Lantus® (insulin glargine) (July 2021) and was launched in November 2021. Eli Lilly’s insulin glargine biosimilar, Rezvoglar®, was FDA-approved in December 2021. Rezvoglar® later received approval as an interchangeable biosimilar to Lantus® in November 2022, ahead of its US launch in April 2023. In October 2025, Biocon announced its plans to supply a new insulin glargine medicine in the US in collaboration with Civica.