US pharmaceutical company Lannett, its wholly owned subsidiary Lanexa Biologics, and China-based Sunshine Lake Pharma have received US Food and Drug Administration approval for LANGLARA™, an interchangeable biosimilar of Lantus® insulin glargine for the treatment of adults and paediatric patients with type 1 diabetes and adults with type 2 diabetes, according to Yahoo Finance UK.

The FDA has designated LANGLARA as interchangeable with the reference drug, enabling pharmacists to substitute LANGLARA for Lantus without prescriber intervention in states that permit such substitution, a designation that requires additional regulatory requirements beyond standard biosimilar approval.

Tim Crew, chief executive of Lannett, said: "Often, the greatest barrier to care for patients living with diabetes is the cost or the availability of the medicine itself. Upon the launch of LANGLARA, supported by the tremendous manufacturing scale of our partner, patients will have expanded access to a safe, affordable and available treatment option."

Richard Tang, President of HEC Group, said the approval reflects the significant investment both companies made in bringing affordable insulin to patients in the United States, with Sunshine Lake Pharma making substantial commitments to support the production scale necessary to be a meaningful supplier of the medicine.

LANGLARA is manufactured by Sunshine Lake Pharma, the pharmaceutical arm of HEC Group, and will be commercialised exclusively in the United States through Lanexa Biologics. The approval was based on a comprehensive analytical, preclinical, and clinical programme confirming the efficacy, safety, and immunogenicity profile of LANGLARA compared to Lantus.

Lannett and Sunshine Lake Pharma are also collaborating on a short-acting insulin aspart product currently in development.

Access the full story for comprehensive details on the LANGLARA approval and commercialisation strategy.