Viatris Expects First Interchangeable Biosimilar Designations For Insulins In July

Firm Expecting Landmark Nods For Both Glargine And Aspart

13 May 2021

Amid continued debate over biosimilar interchangeability in the US, Viatris has said it expects to pick up the first such approvals later this year with the company’s insulin glargine and insulin aspart biosimilar products.

FDA building. — July is a key month for Viatris' FDA insulin application • Source: Shutterstock

Viatris expects to obtain the first US Food and Drug Administration approvals for interchangeable biosimilar products later this year, including the already available Semglee (insulin glargine) and the company’s pending biosimilar to NovoLog/NovoRapid (insulin aspart).

“Our 351k [biologics license application application] for insulin glargine for interchangeability is on track for a July FDA goal date,”...