PHILADELPHIA, PA — Lannett Company announced that the U.S. Food and Drug Administration approved LANGLARA, an interchangeable biosimilar to Lantus insulin, expanding the number of lower-cost insulin treatment options available for diabetes patients in the United States.
The product, marketed as LANGLARA (insulin glargine-aldy), was approved for adults and pediatric patients with Type 1 diabetes and adults with Type 2 diabetes, according to the company. The FDA also granted interchangeable designation status, allowing pharmacists in states that permit substitution to dispense LANGLARA in place of Lantus without requiring prescriber approval.
Lannett stated the approval was supported by analytical, preclinical and clinical studies comparing the biosimilar to Lantus across pharmacokinetic, pharmacodynamic, efficacy, safety and immunogenicity measures.
The insulin product will be manufactured by Sunshine Lake Pharma and commercialized in the United States through Lanexa Biologics, a wholly owned subsidiary of Lannett.
Tim Crew indicated the company intends to pursue broad formulary placement following launch, citing affordability and supply availability as major barriers for diabetes patients.
According to the FDA, interchangeable biosimilars meet additional regulatory standards beyond standard biosimilar approval requirements, enabling pharmacy-level substitution under applicable state laws.
Richard Tang indicated Sunshine Lake Pharma expanded manufacturing capacity to support large-scale insulin production for the U.S. market.
Lannett stated the companies are also collaborating on development of a biosimilar insulin aspart product.
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