Biocon Biologics and Viatris Inc.  have received approval from the US Food and Drug Administration for the first interchangeable biosimilar Semglee which is an insulin glargine-yfgn injection for treating diabetes. This will allow pharmacy level substitution and provide convenient access to Semglee. The product launch is expected to happen by the end of the year.

 “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,” says Arun Chandavarkar, M.D., Biocon Biologics.

The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus. This designation means that Semglee can now be substituted for the reference product, Lantus at the pharmacy. FDA has also released new material that contains complete information about these interchangeable biosimilar products explaining in detail to help healthcare providers learn its concepts. 

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First approved as a human insulin analog back in 2020, Semglee is expected to give same results as Lantus as it has been approved for the same indications by USFDA. Also, both the interchangeable biosimilar and its reference product should also provide similar outcomes in patients and no differences should be observed in terms of potency and safety.

Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and paediatric patients with Type 1 diabetes. These products can potentially reduce the costs of treatment for diabetics diagnosed with both type 1 and type 2 diabetes and yet be effective and helpful. It is not recommended for the treatment of diabetic ketoacidosis.

“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,” says Michael Goettler, CEO, Viatris.