Mylan and Biocon have secured approval from the US Food and Drug Administration (FDA) for Semglee (insulin glargine injection) in vial and pre-filled pen presentations to regulate high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes.
According to Mylan, Semglee has an identical amino acid sequence to Sanofi’s Lantus and has approval for the same indications.
Developed jointly by Mylan and Biocon Biologics, Semglee has been approved as a drug product under the 505(b)(2) NDA pathway and is now deemed a biologic under section 351(a) in compliance with the Biologics Price Competition and Innovation Act in line with other insulin products.
Heather Bresch – Mylan CEO said: “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.”
The approval for Semglee has been driven by the results of an analytical, preclinical and clinical program, which includes the INSTRIDE studies, which confirmed the PK/PD, efficacy, safety and immunogenicity of the drug in comparison to Lantus in patients with type 1 and type 2 diabetes.
Dr Christiane Hamacher – CEO and Managing Director of Biocon Biologics said: “We are extremely excited with the opportunity to offer Semglee, co-developed with Mylan and manufactured by Biocon Biologics, to the U.S. market, where millions of patients need more affordable insulin analogs to control their diabetes. Our combined scientific expertise and global scale manufacturing capability complemented by a comprehensive product presentation across vials and pens will enable us to expand patient access to our insulin glargine through our partner Mylan.
“We are making a significant difference to patients in several countries across the world and commercialization of Semglee in the U.S. will further expand affordable access for patients with diabetes. Biocon Biologics is committed to impact 5 million patient lives globally by FY 22.”
Mylan and Biocon Biologic’s insulin glargine has secured regulatory approval in 45 plus countries and is the third product to have been approved by the FDA through their collaboration.