Celltrion

• Stoboclo listed as a preferred product on the CVS Caremark formulary, with originator products excluded, supporting accelerated uptake
• Osenvelt, previously listed on CVS Caremark, secures a competitive advantage as the only biosimilar designated as a preferred product
• Listings secured with three major PBMs within seven months of launch, achieving over 60% reimbursement coverage in the U.S.
• Celltrion remains focused on accelerating sales through a field-based direct sales strategy and strong product competitiveness

INCHEON, South Korea-  Celltrion announced today that Stoboclo (denosumab), its biosimilar treatment for bone-related diseases, has been listed as a preferred product on the formulary of CVS Caremark, one of the three largest pharmacy benefit managers (PBMs) in the United States. With this listing, Celltrion has successfully completed preferred formulary placement on CVS Caremark for both biosimilars referencing Prolia and XGEVA.

As a result of its preferred status, patient reimbursement for Stoboclo will commence on April 1 (local time), providing a solid foundation for expanding market share in the U.S. In particular, the listing of Stoboclo has been accompanied by the exclusion of the originator products from the CVS Caremark formulary, which is expected to further accelerate prescribing. The decision reflects CVS Caremark’s assessment of Stoboclo’s product competitiveness and is expected to have a positive impact on ongoing formulary discussions with other PBMs and insurers.

Meanwhile, Osenvelt, which was listed on the CVS Caremark formulary ahead of Stoboclo, has been designated as the sole biosimilar preferred product, securing a clear competitive advantage. As the only reimbursed biosimilar for CVS Caremark members in its oncology indication, Osenvelt is expected to further strengthen its market position and drive prescription growth.

With both Stoboclo and Osenvelt listed on CVS Caremark, Celltrion expects favorable prescribing conditions to extend across healthcare services under CVS Health, the parent company of CVS Caremark. CVS Health is one of the leading integrated healthcare companies in the U.S., operating across PBMs, pharmacy networks, health insurance, and healthcare services, and holds significant influence across the healthcare value chain.

Through this achievement, Stoboclo and Osenvelt have been listed as preferred products on formularies managed by three major PBMs, including two of the three largest PBMs in the U.S. and another large PBM ranked among the top five by market share. This milestone was achieved within approximately seven months of their launch in July 2025, and is estimated to have secured reimbursement coverage exceeding 60% of the U.S. market. The outcome is largely attributable to Celltrion USA’s field-oriented commercial strategy, which focused on targeted engagement with PBMs, healthcare professionals, and key institutions from the early stages of launch.

In parallel, Celltrion plans to continue expanding its presence in the U.S. open market, which accounts for approximately 30% of the total denosumab market. The open market primarily comprises healthcare institutions supported by U.S. government programs, where pharmaceutical companies’ sales capabilities and product value play a decisive role. Building on its experience from the successful direct sales of its oncology biosimilar Vegzelma (bevacizumab), Celltrion intends to actively leverage its accumulated commercial expertise to support the uptake of Stoboclo and Osenvelt.

“The preferred formulary listing of Stoboclo and Osenvelt with CVS Caremark has established a stable prescribing foundation that supports sales expansion. As Celltrion continues to receive positive evaluations from multiple major U.S. PBMs, we will actively leverage the local commercial networks built through our existing product portfolio to strengthen the early market positioning of Stoboclo and Osenvelt.”said an official at Celltrion.

Meanwhile, Stoboclo and Osenvelt received FDA approval in March 2025 for all approved indications (full label), consistent with those of the reference products. The originator products recorded combined global sales of approximately USD 6.6 billion in 2024, of which approximately USD 4.4 billion, or 67%, was generated in the U.S. market.