Policy & Regulation
Gan & Lee Pharmaceuticals announces completion of two insulin glargine phase three studies
15 October 2021 -

Gan & Lee Pharmaceuticals Co. Ltd (Shanghai: 603087.SH), a China-based manufacturer and distributer of pharmaceutical products, announced on Thursday that it has completed two randomised, multicentre phase three studies that compare biosimilar insulin glargine offered by the company (GL-GLA) to a reference biological product.

Both studies were carried out separately in patients with type 1 (n = 576) and type 2 (n = 567) diabetes mellitus.

The primary objective of the studies that were conducted for 26 weeks was to evaluate the equivalence of treatment-induced immunogenicity between GL-GLA and the reference biologic utilising pre-specified similarity margins. The secondary objectives were to evaluate the equivalence of efficacy and safety. Both studies have indicated that treatment-induced immunogenicity was equivalent. The between-group efficacy estimates were within the pre-specified similarity margins and were found to be equivalent. Safety parameters were comparable between GL-GLA and the reference biologic.

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