Lannett Reports Results of Biosimilar Insulin Glargine in Human Clinical Study to Treat Patients with Type 2 Diabetes

Shots:

• The first clinical study in humans involves evaluation of PK/PD of the Lannett/HEC-insulin glargine vs the reference product, Sanofi’s US approved Lantus after a single SC dose in 27 healthy male adult candidates
• The study resulted in meeting all 1EPs i.e, demonstrating bio-similarity to Sanofi’s Lantus and is safe and well-tolerated with no SAEs
• The biosimilar of insulin glargine is developed under a strategic collaboration of Lannett and HEC with its positive results to be served as a basis to file BLA to the US FDA. The companies are expected to meet FDA in the next month for further clinical advancement including the design of the biosimilar product development plan

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