Recent Insulin Glargine Biosimilar Developments

On Monday the FDA approved Eli Lilly’s insulin glargine biosimilar Rezvoglar, a biosimilar to Sanofi’s Lantus.  Rezvoglar is indicated to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.  Rezvoglar is available in 3 mL prefilled pens and is administered subcutaneously once daily.  Rezvoglar is the second Lantus biosimilar insulin product  approved in the U.S., following the launch of Semglee last month.

Lannett Company, Inc. also announced on Monday its submission of an Investigational New Drug (IND) application with the FDA for a clinical trial of an insulin glargine biosimilar.  Lannett is co-developing the product with partners within the HEC Group of companies.  CEO Tim Crew said the company anticipates filing its abbreviated Biologics License Application in early 2023, and once approved launching its product, likely in early 2024.