Mylan and Biocon's Semglee, biosimilar to Sanofi's Lantus, approved by FDA for type 1 and 2 diabetes

Mylan and Biocon have scored FDA approval with their insulin glargine injection Semglee, a biosimilar to Sanofi’s Lantus, in both pre-filled pen and vial applications for the control of high blood sugar in adults with type 2 diabetes and adults and children with type 1 diabetes.

The decision to approve the drug was based on clinical data showing favourable pharmacokinetics, pharmacodynamics, immunogenicity and safety compared to its rival, Sanofi’s Lantus.

Mylan President Rajiv Malik commented on the decision: "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.”

Semglee’s amino acid sequence is identical to that found in Lantus, and thus is approved for use in the same indications. Sanofi has levied patent claims against Mylan over its insulin glargine products, but the latter firm said that judgements reached by the US Patent and Trademark Appeal Board on these claims have been favourable, and while Sanofi may attempt to appeal these judgements, Mylan said it was confident this would not affect its marketing plans.

"We are extremely excited with the opportunity to offer Semglee, co-developed with Mylan and manufactured by Biocon Biologics, to the US market, where millions of patients need more affordable insulin analogs to control their diabetes” remarked Dr Christiane Hamacher, CEO & Managing Director at Biocon. “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 commercialisation 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."

Matt Fellows