Scatter plot distribution of average relative potency of MYL-1501D, US- and EU-licensed insulin glargine.

(A) IR Phosphorylation in HepG2 Cells, (B) IR-A Phosphorylation in CHO-K1 Cells Expressing IR-A, (C) IR-B Phosphorylation in CHO-K1 Cells Expressing IR-B, (D) Glucose Uptake Activity in 3T3-L1 Cells, (E) Adipogenicity Activity in 3T3-L1 Cells, (F) Inhibition of Stimulated Lipolysis Activity in 3T3-L1 Cells, and (G) Mitogenic Activity by Saos-2 Cells. Multiple lots of MYL-1501D, US-, and EU-licensed insulin glargine were analyzed, and data are expressed as mean ± 95% CI. Each dot represents one lot for which data were collected from 3 independent runs, and mean is presented. Mean ± 3 SD range derived from innovator product is presented as solid green line for US-licensed insulin glargine and dotted blue line for EU-licensed insulin glargine. * P <0.05, ** P <0.01, and *** P <0.001 in TOST/Equivalence test. CHO, Chinese hamster ovary; GOPOD, glucose oxidase/peroxidase; IR, insulin receptor; Saos-2, sarcoma osteogenic cell; TOST, Two One-Sided T-test.