Phase III trials of MK 1293 (insulin glargine biosimilar) meet endpoints in type 1 and 2 diabetes- Merck Inc

Merck has announced results from two Phase III studies evaluating MK 1293 (insulin glargine biosimilar) for the treatment of people with type 1 and type 2 diabetes. In both studies, MK 1293 achieved its primary endpoint by demonstrating non-inferiority in change from baseline A1C (a measure of average blood glucose) and similar safety to Lantus (insulin glargine) after 24 weeks in patients with type 1 and type 2 diabetes. Furthermore, in both studies, MK 1293 met its pre-specified secondary efficacy endpoints of statistical A1C equivalence to Lantus, a measure used to show that an investigational treatment is similar, within an acceptable range, to a current therapy.

Comment: MK-1293 has the same amino acid sequence as Lantus, the originator insulin glargine. The development of MK-1293 builds on an agreement between Merck and Samsung Bioepis established in February 2013 to develop and commercialize multiple biosimilar candidates across different therapeutic areas.

Comment: The US patent for Lantus expired in 2015 and the EU patent expires in June 2016. Sanofi has developed a successor to Lantus which is now approved in the US and EU as Toujeo (U300). Eli Lilly & Co.and Boehringer Ingelheim have launched their biosimilar version of Lantus called Abasaglar, in its first major market which is the UK.