Biocon, Mylan receive USFDA approval for the launch of their insulin glargine injection


Biocon Ltd and Mylan NV on Friday announced that they have received approval from the United States Food and Drug Administration (FDA) for the launch of its insulin glargine injection Semglee which is meant to control high blood sugar in adults with diabetes

“The US FDA has approved the New Drug Application (NDA) for Semglee (insulin glargine injection), in vial and pre-filled pen presentations, to control high blood sugar in adults with Type-2 diabetes and adult and pediatric patients with Type-1 diabetes. Semglee has an identical amino acid sequence to Sanofi’s Lantus and is approved for the same indications,” the companies said in a statement.

Semglee has been developed by the India-based Biocon Biologics in partnership with Mylan. It was approved by the USFDA as a drug product under the 505(b)(2) NDA pathway.

With the product being deemed as a biologic under section 351(a) in accordance with the Biologics Price Competition and Innovation Act in line with other insulin products, it becomes the third biologics launched by Biocon in the US.

The approval for the product was sought based on a “comprehensive analytical, preclinical and clinical programmeme (including the INSTRIDE studies).” This programme confirmed the PK/PD, efficacy, safety and immunogenicity of the injection in patients with Type-1 and Type-2 diabetes.

Kiran Mazumdar Shaw, Chairperson, Biocon, said: “The approval of our insulin glargine by the US FDA marks the culmination of a long journey. As an organisation committed to making insulin-based therapy increasingly accessible for people with diabetes globally, I am glad this approval will enable us to serve the needs of patients in the US The approval is also an endorsement of our science, scale and expertise to develop high quality, more affordable insulins and shift the access paradigm in favour of patients, taking us closer to realizing our aspiration of reaching ‘one in five’ insulin-dependent people with diabetes worldwide.”

The commercialisation of this insulin glargine injection in the US will further expand the affordability and accessibility of such products for diabetic patients as per the company.

“This approval is an important milestone, first and foremost for the millions of patients living with diabetes in the US as we seek to expand their access to insulin through more affordable treatment options,” said Mylan CEO Heather Bresch.

Published on


June 12, 2020

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