Biocon Ltd. and Mylan N.V. today announced that the U.S. Food and Drug Administration has approved the New Drug Application 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.

Kiran Mazumdar Shaw, Chairperson, Biocon, 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.”

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.”

Mylan President Rajiv Malik added: “Today’s milestone makes Mylan the first company to have approvals on both the vial and pen presentations of insulin glargine treatment options to Lantus® and further reaffirms our proven scientific track record in gaining approval for complex products like Glatiramer Acetate, Yupelri®, biosimilars to Neulasta® and Herceptin®, as well as a drug-device combination product like Wixela® Inhub®. I would like to recognize the extraordinary work and leadership of both Mylan and Biocon’s scientific and regulatory teams for this achievement. As a leading provider of oral diabetes medicine in the U.S., this approval expands our offerings to those living with the disease while further demonstrating the power of the unique platform we’ve built in terms of scientific excellence, strong partnerships and the ability to leverage our regulatory and commercial expertise around the world to bring higher value-chain products to market. Semglee represents another component to our global biosimilars franchise approach in advancing access to complex medicines.”

Malik continued, “Additionally, we believe that the strong comprehensive analytical and clinical program supporting the approval of Semglee will be central to our continued work to achieve interchangeable product status, with the potential to further reduce the cost burden for patients. We look forward to making this product available to patients in the U.S. as soon as possible.”

The approval for Semglee was based on a comprehensive analytical, preclinical and clinical program 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 Biologics 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.