Mylan and Biocon announced the U.S. Food and Drug Administration (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.
Semglee, co-developed by Mylan and Biocon Biologics, was approved as a drug product under the 505(b)(2) NDA pathway and is now deemed a biologic under section 351(a) in accordance with the Biologics Price Competition and Innovation Act in line with other insulin products.
"This approval is an important milestone, first and foremost for the millions of patients living with diabetes in the U.S. as we seek to expand their access to insulin through more affordable treatment options. It's also another milestone for Mylan as we continue to leverage our scientific, commercial, manufacturing and regulatory expertise to benefit patients, and as we enhance our portfolio with increasingly complex and higher value-chain products, like insulin. Leveraging these capabilities, whether through our internal teams or through strong partnerships like the one we've built with Biocon, strengthens our ability to deliver innovative solutions to patients in the U.S. and around the world," Mylan CEO Heather Bresch said.
"The approval of our insulin glargine by the U.S. 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 U.S. 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," Kiran Mazumdar Shaw, Chairperson, Biocon, said.
The approval for Semglee was based on a comprehensive analytical, preclinical and clinical program (including the INSTRIDE studies) which confirmed the PK/PD, efficacy, safety and immunogenicity of Semglee in comparison to Lantus in patients with type 1 and type 2 diabetes.
Favorable judgments on all remaining patent claims asserted by Sanofi against Mylan's insulin glargine products have been obtained. Although Sanofi may seek certain appeals of those judgments, Mylan is confident they will not affect commercialization plans.
Sanofi's total IQVIA sales for the 12 months ending April 30, 2020 were approximately $1.68 billion for Lantus 100 Units/mL Vial and approximately $4.33 billion for Lantus SoloSTAR Pen.
Mylan and Biocon Biologic's insulin glargine has received regulatory approval in more than 45 countries around the world and is the third product approved by FDA through the Mylan-Biocon Biologics collaboration.