MSD insulin glargine biosimilar meets primary endpoint in late-stage trials
pharmafile | June 14, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | MSD, Merck, biosimilar, insulin, insuline glargine
MSD (NYSE: MRK), known as Merck in the US and Canada, has announced results from two Phase III studies evaluating its insulin glargine biosimilar candidate, MK-1293.
In both trials, the biosimilar achieved its primary endpoint by demonstrating non-inferiority in change from baseline average blood glucose measure A1c, as well as similar safety to Lantus (insulin glargine) after 24 weeks in patients with type-1 and type-2 diabetes. Furthermore, the biosimilar also demonstrated statistical A1c equivalence to Lantus in these trials, showing that its similarity is within an acceptable range.
The development of this drug builds on a 2013 agreement between MSD and Samsung Bioepis to develop and commercialise multiple biosimilar candidates across different therapeutic areas. Under the terms of a subsequent 2014 agreement, MSD will handle clinical development, manufacturing and, if approved, commercialisation of MK-1293. Samsung Bioepis continues to partially fund its development.
Peter Stein, VP of late stage development in diabetes at MSD, says: “The investigational agent MK-1293 represents [MSD’s] entry into insulin therapeutics and into treatments that may be useful for patients with type-1 diabetes, and we are pleased with these Phase III results. As a follow-on biologic, MK-1293 has the potential to offer a treatment option for paediatric and adult patients with type-1 diabetes and for adults with type-2 diabetes who use basal insulin to help control their glucose levels.”
The results were presented at the 76th Scientific Sessions of the American Diabetes Association.
Sean Murray
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