Viatris Expects First Interchangeable Biosimilar Designations For Insulins In July
Firm Expecting Landmark Nods For Both Glargine And Aspart
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.
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A further voluntary recall for Viatris’ insulin glargine biosimilar, this time for one of its recently launched interchangeable products, because of missing labels may draw unwanted interest from the US FDA, a leading analyst has warned.
Six Form 483 observations of GMP deficiencies have been received from the US FDA by Biocon after the agency inspected the Malaysian manufacturing facility for its insulin aspart biosimilar. However, the Indian firm – which is partnered with Viatris on the product, for which an interchangeability designation is also being sought – insisted that US commercialization plans would not be affected.
Viatris has revealed its commercial strategy for its Semglee insulin glargine biosimilar in the US after winning a landmark first designation of interchangeability for the product from the FDA that will allow pharmacy-level substitution with a year of exclusivity.