Shots:

• The company completes two P-III studies that compares proposed biosimilar Gan & Lee insulin glargine (GL-GLA) to a reference biologic n subjects with type 1 (n=576) and type 2 diabetes mellitus (n=567) for 26wks.
• The focus of the study is to assess the equivalence in treatment-induced (TI) immunogenicity between GL-GLA and the reference biologic using pre-specified similarity margins while the secondary objectives were to assess the equivalence in efficacy and evaluate safety
• Both studies concluded there was equivalent TI immunogenicity with equivalent efficacy outcomes whereas safety endpoints were comparable between GL-GLA and the reference biologic

Ref: Gan & Lee | Image: WebsEdge