Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) and Viatris Inc. and today announced that the U.S. Food and Drug Administration (FDA) has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathway.

Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said: “We are extremely proud to be the first to obtain approval of an interchangeable Biosimilar product in the U.S. It is a milestone achievement for both Biocon Biologics and our partner Viatris. This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine.”

Biocon Biologics Managing Director Arun Chandavarkar said: “This interchangeability approval for Semglee by the U.S. FDA, another first to our credit, is a testament to our scientific excellence and robust quality comparability data. This allows substitution at the pharmacy counter, thus expanding patient access and sets the stage for future approvals for our other insulin products.”

The interchangeable Semglee product, which will allow substitution of Semglee for the reference product, Lantus, at the pharmacy counter, will be introduced before the end of the year. The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus. Commercial preparations for launch are underway. Over the next few months, Viatris will transition the current product to the 351(k) interchangeable product.

Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes. It is not recommended for the treatment of diabetic ketoacidosis. Semglee has an identical amino acid sequence to Lantus and is approved for the same indications.

Viatris CEO Michael Goettler commented: “We are extremely proud to achieve the industry’s first approval of an interchangeable biosimilar product in the U.S., which will help broaden access to this important diabetes medicine for patients, physicians, payers and providers. This is yet another important milestone for our company that not only continues to underscore the strength of our internal scientific capabilities, but also supports our belief in the promising future of our company as we continue to work to identify innovative ways to increase access to complex treatments for patients.”

Viatris President Rajiv Malik added: “We are very pleased to have once again worked with the FDA to achieve the very historic approval of the first interchangeable biosimilar in the U.S. and are grateful to our partner, Biocon Biologics, for their collaboration in achieving this milestone. Our continued ability to break down barriers to access, bring forth first-to-market products and blaze new trails is a testament to the strength of our scientific, regulatory, operations and legal expertise as well as our focus on patients.”

Viatris and Biocon Biologic’s insulin glargine has received regulatory approval in more than 60 countries around the world and was the third product approved by the FDA through the Viatris-Biocon Biologics collaboration.

Important Safety Information
Semglee is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is not recommended for the treatment of diabetic ketoacidosis. Do not use during episodes of hypoglycemia or if hypersensitive to insulin glargine or it’s excipients. Patients should be instructed to never share the prefilled pen even if the needle is changed. Changes to a patient’s insulin regimen should be done under close medical supervision with increased frequency of blood glucose monitoring as hyper- or hypoglycemia may occur. Hypoglycemia is the most common adverse reaction with insulin, including Semglee and it may be life-threatening. Increase frequency of glucose monitoring when there are changes to: insulin dosage, coadministered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. Patients and caregivers must be educated to recognize and manage hypoglycemia. Medication errors can result from accidental mix-ups among insulin products. Instruct patients to always check the insulin label before injection. Severe, life-threatening generalized allergy, including anaphylaxis can occur with insulin products, including Semglee. If hypersensitivity reaction occurs, discontinue Semglee and treat per standard of care and monitor until symptoms and signs resolve.  Monitor potassium levels for hypokalemia and treat if indicated. Fluid retention and heart failure have been reported with concomitant use of thiazolidinediones (TZD). Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation of TZD if heart failure occurs.