July 28th 2021 marked a milestone in biosimilar development. The US FDA approved the country’s first interchangeable biosimilar product-a once daily treatment for diabetes, marketed as “Semglee®”. In the US, the term “interchangeable” means that the marketed product can be substituted automatically by pharmacists without permission from a clinical prescriber, and so similar to the situation with generic drugs. Products that are approved as “normal”, rather than interchangeable, biosimilars are not permitted to be substituted.
Semglee® (insulin glargine-yfgn), manufactured by Biocon Biologics and distributed by Mylan (Viatris), has been approved by the FDA to be both biosimilar to and interchangeable with its reference product, Lantus (insulin glargine), manufactured by Sanofi. Insulin glargine is a long-acting human insulin analog prescribed to enhance glycemic control in both adults and children with Type 1 diabetes and adults with Type 2.
Semglee had already gained approval back in 2020 and has been commercially available since then. This news is the granting of a separate approval of interchangeable biosimilar status, sought to improve the product’s marketability. As this is the first interchangeable insulin biosimilar to Lantus, FDA approval grants it 12 months exclusivity before another interchangeable biosimilar to Lantus can be approved.