Sanofi Reports Results of Biosimilar Insulin Lispro Demonstrated Similar PK and PD Parameters to Humalog
Shots:
- The P-I study evaluates SAR342434 (0.3-U/kg, SC) vs insulin lispro (Humalog) in 36 healthy male patients with T1D or T2D
- The results showed that SAR-Lis had similar PK exposure and glucose pharmacodynamic activity compared with Japanese-approved insulin lispro formulation supporting the use of SAR-Lis as a biosimilar product, no serious AEs, AEs of special interest, or TEAEs leading to treatment discontinuation
- Additionally, a few clinically significant abnormalities in laboratory tests and ECG parameters were observed with no notable difference b/w SAR-Lis and the reference Humalog. SAR-Lis was the first insulin lispro biosimilar authorized in the EU in 2017 and in Japan in 2020
Ref: Centre for Biosimilars | Image: Sanofi
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