Mylan, Biocon receive FDA nod for 'follow-on' insulin glargine Semglee

Mylan and Biocon's Semglee (insulin glargine injection) is now the second approved "follow-on" biologic of Sanofi's Lantus. Adults with Type 2 diabetes, and adult and pediatric patients with Type 1 diabetes will soon be able to obtain a generic treatment to control their blood sugar.

The Food and Drug Administration approved Semglee in vial and pre-filled pen presentations. It is indicated to control high blood sugar in adults with Type 2 diabetes and adult and pediatric patients with Type 1 diabetes. 

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

Mylan's Semglee, like Eli Lilly's Basaglar, which was approved in 2015, is what is called a "follow-on" product to Lantus based on the approval pathway under which it was approved, specifically, Section 505(b)(2) of the Food, Drug, and Cosmetic Act. 

Mylan president Rajiv Malik said, "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.”

Sanofi's Lantus 100 Units/mL Vial had a market value of approximately $1.68 billion, and Lantus SoloSTAR Pen had a market value of roughly $4.33 billion, for the 12 months ending April 30, 2020, according to IQVIA.