Celltrion Launches Affordable Biosimilars in the U.S. Market: A Game Changer for Patients!

South Korean biopharmaceutical powerhouse Celltrion announced Tuesday the launch of its denosumab biosimilars, Stoboclo and Osenvelt, in the lucrative U.S. market, estimated to be worth around 9 trillion KRW ($6.5 billion).

The biosimilars have received the green light for all indications of their reference drugs, Prolia and Xgeva, following Celltrion’s successful acquisition of full-label FDA approval in March and the finalization of a patent settlement with the original manufacturer. Priced approximately 5% lower than their brand-name counterparts, these products will be distributed directly through Celltrion’s U.S. subsidiary.

To ensure a smooth market entry, Celltrion has inked a supply agreement with a major U.S. hospital group, guaranteeing product availability from day one. The company is setting its sights on rapidly expanding its foothold in the U.S. “open market,” which represents 30% of the denosumab segment and is less susceptible to the influence of pharmacy benefit managers.

The biotech giant anticipates a boost in revenue from this launch, considering that the original drugs, Prolia and Xgeva, raked in a combined global revenue of approximately 9.2 trillion KRW in 2024 worldwide.

“Stoboclo and Osenvelt will not only diversify treatment options for U.S. patients but also enhance accessibility,” stated Thomas Nusbickel, chief commercial officer of Celltrion USA. “We’re optimistic about our ability to drive prescription growth and secure market share through both open market and PBM channels.”