MSD files Lantus biosimilar with FDA
pharmafile | August 8, 2016 | News story | Sales and Marketing | FDA, Lantus, MK-1293, MSD, application, biosimilar
MSD, known as Merck in the US and Canada, has filed a new drug application with the US Food and Drug Administration (FDA) for MK-1293, a biosimilar candidate for Sanofi’s Lantus (insulin glargine) in the treatment of type-1 and type-2 diabetes.
The regulatory submission includes results of two Phase III studies which directly compared it with Sanofi’s Lantus. In these trials, the biosimilar demonstrated non-inferiority in change from baseline average blood glucose measure A1c.
MSD made a similar submission to the European Medicines Agency late last year, with the application currently under review. MK-1293 was developed by MSD with partial funding by Samsung Bioepis.
Peter Stein, vice president of late development in diabetes at MSD, says: “The FDA acceptance of our follow-on biologic application is an important milestone, and brings us closer to offering another treatment option for people in the US with diabetes. We are proud of the significant contributions we have already made to helping people with type-2 diabetes, and with investigational MK-1293, we hope to expand our portfolio into insulin therapeutics and treatments for people with type-1 diabetes.”
Sean Murray
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