FDA Accepts Merck’s Lantus Biosimilar for Review

Biosimilar News

We recently posted that Merck had announced “promising” results from Phase III studies evaluating MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes.  Late last week, Merck announced that the FDA had accepted for review its New Drug Application (NDA) for MK-1293.  Interestingly, Merck’s NDA was filed through the 505(b)(2) regulatory pathway, which allows the FDA to reference previous findings of safety and efficacy for the already-approved Lantus, in addition to reviewing findings from studies of MK-1293.  The NDA submission includes Phase I studies assessing its pharmacokinetic and pharmacodynamics properties, and the results of two Phase III studies in patients with both type I and type II diabetes.

Stay tuned to the Big Molecule Watch Blog for further developments.

 

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