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Basal Insulin

December 04, 2019

Positive Lannett Bs-Glargine Ph1 Results; Zealand Initiates 2nd Ph3 CHI Study

Here is a brief preview of this blast: Lannett has announced positive results from the Ph1 PK/PD study evaluating their biosimilar insulin glargine vs. Lantus, which initiated in June 2019. In light of meeting all primary endpoints, Lannett indicated they are planning to meet with FDA to discuss the next steps for bs-glargine development. Below, FENIX provides context and insights, particularly related to the FDA's recent biosimilar insulin draft guidance.