Biocon Biologics and Viatris receive US FDA approval for maiden interchangeable biosimilar Semglee

Biocon Biologics and Viatris have announced that the US Food and Drug Administration (FDA) has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathway, the companies said in a joint statement.

Speaking in this regard, Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Biologics, said, “We are proud to be the first to obtain approval of an interchangeable biosimilar product in the US. 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 biosimilar insulin glargine.”

The statement mentioned that 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.

According to the statement, 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.

Michael Goettler, CEO, Viatris, commented, “We are proud to achieve the industry’s first approval of an interchangeable biosimilar product in the US which will help broaden access to this important diabetes medicine for patients, physicians, payers and providers. This is yet another 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.”

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, said the statement.