Celltrion's Stoboklo Listed as a Preferred Drug by One of the Top 3 U.S. PBMs
by Kwak Minjae
Published 06 Feb.2026 13:14(KST)
Listed as a Preferred Drug in the CVS Formulary
Original Product Removed, Signaling Faster Prescription Growth
Three Major PBMs Secured Within Seven Months of Launch
Over 60% Reimbursement Coverage in the U.S. Market
Celltrion announced on the 6th that Stoboklo (ingredient: denosumab), a treatment for bone disorders, has been listed as a preferred drug in the formulary of CVS Caremark, one of the three largest pharmacy benefit managers (PBMs) in the United States.
Patient reimbursement for Stoboklo will begin on April 1 (local time). The company is being evaluated as having established a bridgehead for expanding its market share in the United States. In particular, with this listing, the original reference product has been removed from the CVS formulary, and the prescription rate of Stoboklo is expected to increase rapidly.
Previously, Osenbelteu, which had been listed with CVS Caremark, was selected as the sole preferred biosimilar, beating out competing products. As Osenbelteu, an anticancer therapy, is the only biosimilar product eligible for cost reimbursement for CVS insurance subscribers, it is assessed that a favorable environment has been created for expanding prescriptions.
The two products have been listed as preferred drugs in the formularies under the control of three PBMs in total: two of the three largest PBMs in the United States and one large PBM that ranks fifth in market size. This achievement came about seven months after their launch in July last year, and it is estimated that they have secured reimbursement coverage for more than 60% of the U.S. market. Analysts say this was driven by the on-the-ground sales strategy of Celltrion’s U.S. subsidiary, which, starting from the time of product launch, carried out tailored marketing targeting local stakeholders such as PBMs, healthcare professionals, and institutions.
Alongside PBM negotiations, Celltrion plans to aggressively target the “open market,” which accounts for about 30% of the U.S. denosumab market. The open market is a segment in which the U.S. government provides direct support to medical institutions. Celltrion is already achieving results in the open market through direct sales of its anticancer biosimilar Vegzelma (ingredient: bevacizumab), and it intends to leverage this experience for Stoboklo and Osenbelteu as well.
A Celltrion official said, “With Stoboklo and Osenbelteu being listed as preferred drugs by CVS Caremark, a major PBM in the United States, we have secured a stable foundation for prescriptions,” adding, “We will make every effort to preempt the market by utilizing the human networks we have built locally.”
Meanwhile, Stoboklo and Osenbelteu received approval from the U.S. Food and Drug Administration (FDA) in March last year for all indications identical to the original products. The original products recorded global sales of approximately 6.599 billion dollars (about 9.2 trillion won) in 2024, of which roughly 4.392 billion dollars (about 6.15 trillion won), or 67% of the total, came from the United States alone.
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