U.S. FDA Approves Mylan’s Semglee Insulin Product

Mylan’s Semglee was approved by the U.S. Food and Drug Administration, with indications that it can improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus, the agency said in an e-mailed statement.

• The approved NDA was deemed to be an approved biologics license application and can therefore be a reference product for a proposed insulin glargine biosimilar or interchangeable biosimilar product

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Greg Chang in San Francisco at gchang1@bloomberg.net

To contact the editor responsible for this story:
Chakradhar Adusumilli at cadusumilli@bloomberg.net

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