Biocon Reports P-I Study (RHINE-3) Results of Biosimilar Insulin
Shots:
- The P-I study (RHINE-3) evaluating a single dose of 0.4IU/kg of Biocon's Insulin-70/30 vs US-licensed Humulin-70/30 vs in a ratio (1:1) in 78 patients
- The results showed a PK & PD equivalence b/w the biosimilar insulin-70/30 and Humulin-70/30 as a single SC administration for the primary EPs. The study also showed equivalence for the secondary PK/PD EPs & was well-tolerated with no clinically relevant differences in the safety profiles & no serious AEs were reported
- Additionally, plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 24hrs., no serious AEs, deaths, or discontinuations due to safety or tolerability reasons were reported
Ref: CrenterforBiosimilar | Image: Biocon
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