Shots:
- The US FDA has approved Langlara, an interchangeable biosimilar to Lantus (insulin glargine), for the treatment of adults & pediatric patients with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus
- Approval was based on the extensive data, incl. analytical, preclinical & clinical program, showing non-inferiority of Langlara to Lantus in terms of PK/PD, efficacy, safety profile & immunogenicity in pts with type 1 & type 2 diabetes
- Langlara is manufactured by Sunshine Lake Pharma, the pharmaceutical arm of HEC Group, & is exclusively commercialized in the US through Lanexa Biologics, a newly formed wholly owned subsidiary of Lannett Company
Ref: Businesswire | Image: Lannett & Sunshine Lake Pharma |Press Release
Related News: Sandoz Receives EC Approval of Ondibta (Biosimilar, Lantus and SoloStar)
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