Viatris’ Interchangeable Semglee Lands On Express Scripts Formulary
Company To Adopt ‘Dual Product Approach’ With Authorized Version
Months after obtaining the first US FDA designation of interchangeability, for its Semglee biosimilar to Sanofi’s Lantus, Viatris has seen a return on its investment, with the biosimilar scooping preferred status on one of the largest national formularies in the US.
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Eli Lilly has been granted an interchangeability designation by the US FDA for its Rezvoglar insulin glargine biosimilar, matching the designation previously granted for Viatris’ Semglee.
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.
Biocon anticipates significant US uptake of its Viatris-partnered interchangeable insulin glargine biosimilar on the back of commercial arrangements in place and expects to "move the market" in 2022. All eyes are also on the trajectory of biosimilar insulin aspart, which received a CRL from the US FDA.