Shots:

• The study evaluating PK/PD parameters in 42 healthy male participants aged 18-55yrs. and were randomized to single doses of the reference product and the biosimilar
• Insulin-R demonstrated PK/PD equivalence to Humulin-R in the study & both were well tolerated. The PK 1EPs were AUC ins and Cmax within the predefined equivalence margins of 80% -125%. For PD, 1EPs were AUC GIR and GIRmax & showed 90% CIs
• The study also showed the PK 2Eps & all PD 2EPs also met the equivalence criteria, no SAEs were reported with no differences in the safety profile. The proposed biosimilar showed similarity in structure and function in physicochemical analyses and nonclinical studies

Ref: Center for Biosimilars | Image: TSK Design