Biocon gets US FDA nod to launch insulin glargine

Biocon and Mylan have got a US food and drug administration nod to launch for its 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.
The product branded as Semglee has an identical amino acid sequence to Sanofi’s Lantus® and is approved for the same indications. This is the third biologics that Biocon will launch in the US.

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.

“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:

Dr Christiane Hamacher, CEO & Managing Director, 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.”

She added: “The global INSTRIDE clinical studies have demonstrated no difference in safety, efficacy and immunogenicity of Semglee in comparison to the reference product, Lantus, in type 1 and type 2 diabetes. Our goal is to enable access to patients in need of insulins, and we are working towards creating a patient ecosystem that helps in lowering co-morbidities and achieving overall cost savings for the healthcare systems.”

Mylan CEO Heather Bresch 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.”