Merck’s biosimilar insulin glargine candidate MK-1293 shined in two Phase 3 studies, meeting its primary endpoint of non-inferiority compared to Sanofi’s Lantus in patients with Type 1 and Type 2 diabetes.
In both studies, the biosimilar showed non-inferiority in change from baseline A1C with a similar safety profile. The candidate also met its secondary efficacy endpoint of statistical A1C equivalence to Lantus.
Development of the biosimilar is being conducted under an agreement with Samsung Bioepis, under which Merck is tasked with leading clinical development and manufacturing. If accepted, Merck also will be responsible for commercializing the product, while Samsung is partially funding development.