- The US FDA’s approval is based on comprehensive analytical, preclinical, and clinical programs (including the INSTRIDE (1&2) studies assessing MYL-1501D (qd) vs Lantus in 558 T1DM & 560 T2DM patients for 52wks. & 24wks. respectively. The 1EPS is changed from baseline in HbA1c after 24 wks.
- The INSTRIDE demonstrated no difference in safety, efficacy, and immunogenicity of Semglee in comparison to Lantus in T1D & T2D. The drug is approved under the 505(b) NDA pathway and is a deemed a biologic under section 351(a) in accordance with the Biologics Price Competition and Innovation Act in line with other insulin products
- Semglee has an identical amino acid sequence to Sanofi’s Lantus and is approved in vials and pre-filled pen presentations, to control high blood sugar in adults with T2D and adult and pediatric patients with T1D. Semglee has received regulatory approval in 45+ countries across the world and is the third product approved by the FDA through the Mylan-Biocon biologics collaboration
Click here to read full press release/ article | Ref: Buinesswire | Image: Pharmaworld