728-P: Mylan Insulin Aspart (MYL-1601D) Is Bioequivalent to Novolog (U.S.-Licensed Insulin Aspart) and NovoRapid (EU-Approved Insulin Aspart)

Pharmacokinetics (PK) and pharmacodynamics (PD) of proposed biosimilar Insulin Aspart (MYL-1601D) vs. NovoLog and NovoRapid were compared in a randomized, double-blind, crossover, clamp study. 71 healthy subjects received a single subcutaneous dose (0.2 U/kg) of each formulation under automated euglycemic clamp conditions (ClampArt®, level 81 mg/dl, duration 12h post-dose). Insulin aspart in plasma was quantified using immunoaffinity purification followed by UPLC and tandem mass spectrometric detection. The primary PK and PD results are provided in Table 1. The secondary PK-endpoints (AUCIns.04h, AUCIns.0-6h and AUCIns.0-∞) and PDendpoints (AUCGIR_04h, AUCGIR_0-6h and AUCGIR_6-last) also met BE criteria. Safety was comparable between all three insulin aspart products.