Celltrion Signs Formulary Listing Agreement for "Storvochlo-Osenbelt" with Major U.S. PBM

Proven Product Competitiveness as the Only Biosimilar Listed
Secures Preferred Drug Status with Additional PBMs, Establishing Early Reimbursement Foundation

Celltrion announced on December 1 that it has signed a formulary listing agreement for its osteoporosis treatment, "Strovoclo-Ocenbelt" (ingredient: denosumab), with one of the top three pharmacy benefit managers (PBMs) in the United States.

Celltrion

Through this agreement, Strovoclo-Ocenbelt has not only been listed on all public and private insurance formularies managed by the PBM, but it has also secured preferred drug status, making it eligible for priority prescriptions. The listing will take effect starting January next year, at which point patients will be able to receive reimbursement, leading to expectations of rapid prescription growth.

Strovoclo-Ocenbelt is drawing attention as it is the only denosumab biosimilar currently listed on formularies in the United States. Celltrion stated, "This demonstrates that Strovoclo-Ocenbelt's product competitiveness has been highly recognized by the top three PBMs, which have significant influence in the U.S. pharmaceutical market."

Celltrion's U.S. subsidiary has also signed a formulary listing agreement for Strovoclo-Ocenbelt with another major PBM, which ranks fifth in market size. In this case as well, the product has been listed as a preferred drug on all public and private insurance formularies managed by the PBM, with patient reimbursement set to begin in January next year.

In the United States, where drug prices are high, reimbursement is only available for drugs listed on formularies managed by PBMs, making agreements with PBMs essential. Considering this market characteristic, the fact that Strovoclo-Ocenbelt has secured listings with two of the top five PBMs within just four months of its launch is seen as evidence of strong market expectations for the product's competitiveness and sales potential from the outset. Including these two PBMs, Celltrion currently estimates that Strovoclo-Ocenbelt's U.S. market coverage stands at approximately 30%.

Celltrion is also rapidly pursuing formulary listing agreements with the remaining two major PBMs. In the private insurance sector managed by these PBMs, the listing agreement for Ocenbelt has already been completed, and only the additional listing agreement for Strovoclo remains in its final stages. Celltrion plans to swiftly finalize public insurance agreements with these PBMs as well, aiming to complete formulary listings with all major PBMs in the United States and quickly expand its overall market coverage.

Thomas Nussbaumer, Chief Commercial Officer (CCO) of Celltrion's U.S. subsidiary, stated, "With the rapid completion of Strovoclo-Ocenbelt's listings with major PBMs, we have successfully established a foundation to provide high-quality biopharmaceuticals to American osteoporosis patients at reasonable prices. We will make every effort to leverage our established human network to quickly capture the U.S. osteoporosis treatment market and drive performance growth by expanding the product's influence."

Meanwhile, with the successful market entry of this newly launched product, Celltrion's future sales growth is expected to accelerate further. The original product of Strovoclo-Ocenbelt, Prolia-Xgeva, recorded combined global sales of approximately $6.599 billion (about 9.2 trillion won) last year, with U.S. sales alone accounting for about $4.392 billion (about 6.15 trillion won), representing 67% of total sales.

This content was produced with the assistance of AI translation services.