Mylan and Biocon Receive the US FDA’s Approval for Semglee (biosimilar, insulin glargine)

 Mylan and Biocon Receive the US FDA’s Approval for Semglee (biosimilar, insulin glargine)

Mylan and Biocon Receive the US FDA’s Approval for Semglee (insulin glargine injection)

Shots:

  • 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

Related News: Biocon and Mylan Launch Semglee (biosimilar, Insulin Glargine) in Australia

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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