Traditional Drug Pipeline Monthly Update: November 2022

This monthly pipeline wrap-up provides a review of newly approved traditional drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

See separate articles for pipeline information on specialty drugs.

New Drug Information

• Rezvoglar^® (insulin glargine-aglr): The U.S. Food and Drug Administration (FDA) approved the second interchangeable biosimilar insulin product to Lantus^® (insulin glargine), Eli Lilly’s Rezvoglar^® (insulin glargine-aglr).¹Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. FDA previously approved Rezvoglar as a biosimilar to Lantus on December 17, 2021.

Generic Drug Information

• Daliresp^® (roflumilast tablet): Multiple manufacturers have launched their generic version of AstraZeneca’s Daliresp for the treatment of chronic obstructive pulmonary disease (COPD). Daliresp generated $260 million in U.S. annual sales in 2021.

+Specialty medication

References

1. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761215