FDA Approves Semglee, Its First Interchangeable Biosimilar Insulin Product

The US Food and Drug Administration (FDA) has approved the first interchangeable biosimilar product for the treatment of diabetes with the approval of insulin glargine-yfgn (Semglee) to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes, according to the FDA.

In their press release, the FDA noted the Semglee is both biosimilar to and interchangeable with its reference product insulin glargine (Lantus), a long-acting insulin analog marketed by Sanofi Pasteur. The release also noted approval of insulin glargine-yfgn injection was granted to Mylan Pharmaceuticals, which is part of Viatris Inc.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Janet Woodcock, MD, in the FDA’s press release. “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

Announced on July 28, Viatris Inc. plans for insulin glargine-yfgn to be available commercially in the US before the end of 2021, according to a release from Viatris Inc. With approval, Viatris is eligible to have exclusive marketing right for 12 months before the FDA can approve another biosimilar interchangeable to Lantus. Additionally, the company noted plans to transition the product to the 351(k) interchangeable product.

"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 US 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,” said Rajiv Malik, President of Viatris, in a press release from the company.

When launched, insulin glargine-yfgn will be offered in 10 mL vials and 3 mL refilled pens. According to the FDA, approval of the biosimilar was based on evidence demonstrating the products were highly similar and there were no clinically meaningful differences in terms of safety, purity, and potency.