Viatris (NSDQ:VTRS) and Biocon Biologics announced FDA clearance for their Semglee insulin glargine-yfgn injection as a biosimilar.
Semglee holds an indication for controlling high blood sugar in adults with type 2 diabetes and pediatric patients with type 1 diabetes. The FDA approved Semglee as the first interchangeable biosimilar product under the 351(k) regulatory pathway. The product is sold in a pre-filled disposable pen.
The product already holds approval in more than 60 countries worldwide, having garnered European and Australian approval in 2018.
“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,” Viatris CEO Michael Goettler said in a news release. 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.”
According to the release, the interchangeable product clearance will allow for the substitution of Semglee for the reference product, Lantus, at the pharmacy counter . Product introduction is planned before the end of the year. The company is eligible for 12 months of exclusivity before the FDA can approve another biosimilar interchangeable to Lantus.
“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,” Biocon Biologics managing director Arun Chandavarkar said. “This allows substitution at the pharmacy counter, thus expanding patient access and sets the stage for future approvals for our other insulin products.”