FDA clears interchangeable insulin biosimilar Semglee

The Food and Drug Administration has approved the first interchangeable biosimilar product, Mylan’s Semglee (insulin glargine-yfgn).

Semglee is both biosimilar to and interchangeable with Lantus (insulin glargine).  

As an interchangeable biosimilar product, Semglee may be substituted for Lantus at the pharmacy-level without the intervention of the prescribing health care provider, subject to state pharmacy laws.

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. 

"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," said Viatris CEO Michael Goettler."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."

"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," said Viatris president Rajiv Malik. "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."

Semglee, offered in 10 mL vials and 3 mL prefilled pens, is administered subcutaneously once daily.

The interchangeable Semglee product 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.