Mylan and Biocon Launch Semglee (insulin glargine injection) as Vials and Pre-Filled Pen in the US
Shots:
- The companies have launched Semglee (insulin glargine injection) in a vial and pre-filled pen at WAC of $147.98/ package of (5) 3ml pens and $98.65/ 10ml vial- representing the lowest WAC for any long-acting insulin glargine
- The US FDA has approved Semglee for the same indications as to its reference product Sanofi's Lantus- thus expanding access for millions of patients living with diabetes
- Additionally- Mylan has submitted all necessary documentation to the FDA- requesting the approval of Semglee as a biosimilar to Lantus under the 351(k) pathway. Semglee has received regulatory approval in 45+ countries and is the third FDA's approved product under the Mylan-Biocon collaboration
Ref: PRNewswire | Image: Diet Doctor
Related News: Mylan and Biocon Receive the US FDA’s Approval for Semglee (biosimilar- insulin glargine)
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