On May 4, 2026, the FDA approved Lannett Company, Inc. (“Lannett”), Lanexa Biologics LLC (“Lanexa”), and Sunshine Lake Pharma’s LANGLARA (insulin glargine-aldy) as an interchangeable biosimilar to Sanofi’s LANTUS (insulin glargine). LANGLARA is approved for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.
The FDA determined that LANGLARA is interchangeable with LANTUS, such that, subject to state pharmacy laws, pharmacists may substitute LANGLARA for the reference product without intervention from the prescribing healthcare provider. According to the press release, the approval was based on a comprehensive analytical, preclinical, and clinical program demonstrating that LANGLARA has comparable pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity to LANTUS in patients with type 1 and type 2 diabetes. LANGLARA is manufactured by Sunshine Lake Pharma and will be commercialized in the United States exclusively through Lanexa, a subsidiary of Lannett established to serve as a commercial platform for its biosimilar portfolio. LANGLARA is Lanexa’s inaugural insulin product, and a short-acting insulin aspart is also under development.
LANGLARA is the third biosimilar insulin glargine approved by FDA, following approval of Mylan’s SEMGLEE (insulin-glargine-yfgn) in 2021 and Eli Lilly’s REZVOGLAR (insulin glargine-aglr) in 2023.
The post FDA Approves Lannett, Lanexa Biologics, and Sunshine Lake Pharma’s Interchangeable Insulin Glargine Biosimilar appeared first on Big Molecule Watch.