FDA Approves NDA for Semglee (insulin glargine injection)


Mylan and Biocon’s NDA for Semglee (insulin glargine injection), was approved last week by the FDA, making it the third product approved by the FDA through the Mylan-Biocon Biologics collaboration.  Semglee’s amino acid sequence is identical to that of Sanofi’s Lantus, and Biocon’s CEO and Managing Director, Dr. Christiane Hamacher, announced that clinical studies had “demonstrated no difference in safety, efficacy and immunogenicity of Semglee in comparison to the reference product, Lantus, in type 1 and type 2 diabetes.”

As we previously reported, in June the PTAB issued final written decisions finding most of Sanofi’s Lantus patents invalid, and in March, the U.S. District Court of New Jersey found U.S. Patent No 9,526,844, a pen-type injector patent related to insulin glargine, not infringed and invalid for lack of written description, paving the way for Mylan and Biocon’s launch of Semglee.

Semglee is available in vial and pre-filled pens, and indicated for the control of high blood sugar in adults with type 1 and type 2 diabetes, and in pediatric patients with type 1 diabetes.  Mylan’s president Rajiv Malik noted that “the strong comprehensive analytical and clinical program supporting the approval of Semglee will be central to [Mylan and Biocon’s] continued work to achieve interchangeable product status[.]”