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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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.
Biosimilar interchangeability is a hot topic in the US, with the first FDA decision on a formal interchangeability designation expected this month. But across the industry, views differ dramatically on the desirability and likely impact of this additional standard to biosimilarity.