FDA grants interchangeability status to Celltrion's Stoboclo and Osenvelt
South Korea-based Celltrion (Kosdaq: 068270) today announced that the US Food and Drug Administration (FDA) has designated Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) as interchangeable biosimilars to the reference products Prolia (denosumab) and Xgeva (denosumab) from Amgen (Nasdaq: AMGN), respectively, for all approved indications.
The company explained that interchangeability (IC) designation is a regulatory designation granted by the FDA, which means Stoboclo and Osenvelt may now be substituted at the pharmacy for the reference products without consulting the prescriber, subject to state laws.
Amgen reported Prolia sales of $2.88 billion and Xgeva sales of $1.51 billion for full-year 2024, but has since seen sales dropping off as a result of biosimilars compete tion. Among other denosumab biosimilars are Sandoz’s (SIX: SDZ) Wyost and Jubbonti and Fresenius Kabi with Conexxence and Bomyntra.
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