Celltrion said on the 6th that Stubboclo (denosumab), a bone disease treatment, has been listed as a preferred drug on the formulary of CVS Caremark, one of the three largest U.S. pharmacy benefit managers (PBMs).
Stubboclo is a biosimilar to Prolia and XGEVA developed by Amgen. With this listing, both Stubboclo and Osenvelt, which Celltrion launched as biosimilars to the original drugs, have been named preferred drugs on the CVS Caremark formulary.
Stubboclo will be eligible for reimbursement for CVS Caremark insurance members starting Apr. 1 (local time). As a result, prescriptions in the United States are expected to expand. In particular, with this listing, the original product has been removed from the CVS formulary, and Stubboclo's share of prescriptions is expected to grow further.
Osenvelt, which was previously listed on CVS Caremark, secured preferred drug status as the sole biosimilar, beating competing products. Used in cancer treatment, Osenvelt is the only biosimilar eligible for reimbursement for CVS insurance members, creating an environment favorable for prescription growth.
With Stubboclo and Osenvelt listed on CVS Caremark, a favorable prescribing environment is also expected across the broader health care services overseen by CVS Health, the parent company, including insurers and pharmacy chains. CVS Health is a leading U.S. comprehensive health care company with PBM, pharmacy chain, and health insurance businesses.
With this achievement, Stubboclo–Osenvelt has been listed as preferred drugs on the formularies of three major PBMs in total: two of the three largest U.S. PBMs and a large PBM ranked fifth in the market. Achieved about seven months after their launch in July last year, the reimbursement coverage in the U.S. market is estimated to exceed 60%. The company said its tailored sales strategy targeting local medical staff and institutions translated into results.
Stubboclo–Osenvelt received approval from the U.S. Food and Drug Administration (FDA) in Mar. last year for sales across all indications on the full label, identical to the original. As of 2024, the original products recorded approximately $6.599 billion in global sales (about 9.2 trillion won), with U.S. sales of about $4.392 billion (about 6.15 trillion won), accounting for 67% of the total.
Beyond the PBM channel, Celltrion plans to accelerate its push into the "open market," which accounts for about 30% of the U.S. denosumab market. The open market centers on medical institutions supported by the government, where a pharmaceutical company's direct sales capabilities and sales force are the key competitive factors. Based on the direct sales experience accumulated through the anticancer biosimilar Vegzelma (bevacizumab), Celltrion plans to expand the market for Stubboclo–Osenvelt.
A Celltrion official said, "With our listing as a preferred drug on CVS Caremark, we have secured a stable foundation for prescriptions," and added, "Building on our collaboration with major U.S. PBMs, we will actively leverage our local network to focus on expanding market share."