Overview
- The FDA approved Langlara (insulin glargine-aldy) as an interchangeable biosimilar to Sanofi’s Lantus for adults and children with type 1 diabetes and for adults with type 2 diabetes.
- Interchangeability allows pharmacists in states that permit it to substitute Langlara for Lantus without prescriber approval.
- The decision followed analytical and clinical studies showing matched pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity to Lantus.
- Sunshine Lake Pharma of the HEC Group will manufacture Langlara, and Lannett’s Lanexa Biologics will handle U.S. commercialization.
- The approval adds to a crowded glargine market that has pushed list prices down, with one cited analysis reporting a 78% drop for Lantus between 2024 and 2026.