Data shows comparable efficacy, safety and immunogenicity to Lantus in Type I and Type II Diabetes Patients
Mylan and Biocon presented new data from the insulin glargine clinical programme, including the INSTRIDE studies at the American Diabetes Association’s (ADA) 77th Scientific Sessions in San Diego. The studies confirmed the efficacy, safety and immunogenicity of MYL-1501D, insulin glargine, in comparison to Lantus in patients with Type I and Type II diabetes. Data demonstrating pharmacokinetic and pharmacodynamic equivalence also was presented.
Insulin glargine is a long-acting insulin used to treat adults with Type II diabetes, as well as adults and pediatric patients with Type I diabetes, for the control of high blood sugar
Data was presented during the poster session which comprised:
Comparative Pharmacokinetics (PK) and Pharmacodynamics (PD) of a proposed biosimilar Insulin Glargine and Lantus in patients with Type I diabetes (T1D) (Poster #1019-P)
Efficacy and safety of MYL-1501D (Mylan’s insulin glargine) compared with Lantus (Sanofi’s insulin glargine) in patients with Type I diabetes after 52 weeks: The INSTRIDE I study (Poster #1018-P)
Efficacy and safety of MYL-1501D (Mylan’s insulin glargine) compared with Lantus (Sanofi’s insulin glargine) in patients with Type II diabetes after 24 weeks: The INSTRIDE II study (Poster #1017-P)
Comparable Immunogenicity between MYL-1501D (Mylan’s insulin glargine) and Lantus (Sanofi’s insulin glargine) in Patients with Type 1 and 2 Diabetes Mellitus: The Phase III INSTRIDE studies (Poster #1028-P)