Celltrion has expanded formulary coverage with major U.S. pharmacy benefit managers (PBMs), broadening prescription access for its high-margin biosimilar portfolio and strengthening its sales outlook in the U.S. market.

The company said Monday that Avtozma (tocilizumab), a biosimilar for autoimmune diseases, has been added as a preferred drug to the commercial formularies of the three largest U.S. PBMs — Express Scripts (ESI), CVS Caremark, and Optum.

Rebate coverage has been in effect since the first quarter of this year through ESI and Optum, while CVS began applying rebates last month.

The expanded coverage comes about seven months after Avtozma was added to the public and commercial formularies of Prime Therapeutics late last year. Celltrion said it now has rebate-based access to more than half of the U.S. insurance market.

The company is also in discussions with major PBMs to secure formulary placement for the subcutaneous (SC) version of Avtozma, which is scheduled to launch later this year. Celltrion plans to expand market share through differentiated commercial strategies tailored to both intravenous (IV) and subcutaneous formulations.

Celltrion has also broadened prescription access for its denosumab biosimilars, Stoboclo and Osenvelt, used to treat bone diseases.

The products were recently added as preferred drugs to Express Scripts' public formulary. They had previously secured placement on CVS Caremark's commercial formulary and Optum's public and commercial formularies. Osenvelt has also been listed on Express Scripts' commercial formulary, giving the company broad coverage across the three leading PBMs.

Beyond PBM channels, Celltrion said it will continue targeting the U.S. open market, which accounts for roughly 30% of the denosumab market. The company aims to leverage its expanded formulary coverage and direct sales infrastructure to increase market share.

Celltrion expects broader rebate coverage for its newly launched biosimilars to support earnings growth in the second half of the year, noting that products launched shortly after originator patent expirations typically generate higher margins.

"Our recently launched high-margin products have continued to gain preferred formulary status with major U.S. PBMs, expanding rebate coverage while strengthening brand recognition," a Celltrion official said. "With additional product launches and other key milestones planned for the U.S. market in the second half, we expect sales momentum to continue."

Last month, Celltrion reported second-quarter consolidated revenue of $9.29 billion, up 45% from a year earlier, while operating profit rose 86.3% to $3.01 billion, marking record quarterly revenue.

Celltrion has expanded formulary coverage with major U.S. pharmacy benefit managers (PBMs) …

Celltrion expands U.S. PBM coverage, boosting outlook for high-margin biosimilars