Celltrion's high-margin biosimilars land on all three major US PBM formularies, accelerating second-half prescriptions

Celltrion is accelerating second-half prescription growth in the United States by securing consecutive formulary listings for its high-margin biosimilars with the country's largest pharmacy benefit managers.

According to Celltrion on Monday, its autoimmune disease treatment Aptozma (tocilizumab) has been listed as a preferred drug on the private-insurance formularies of all three major US PBMs — Express Scripts, CVS Caremark and Optum.

Aptozma was first listed on the formulary of Prime Therapeutics, another top-tier PBM, in December last year. With Monday's announcement, the drug has secured a presence across all three major PBMs' private-insurance segments within roughly seven months of its US launch, giving it reimbursement coverage for more than half of the entire US insurance market. Patient reimbursement through Express Scripts and Optum took effect from the first quarter of this year, while CVS coverage began last month.

Celltrion plans to leverage the three-PBM listing milestone to aggressively pursue early formulary listing negotiations for a subcutaneous formulation of Aptozma, which is set to launch in the US this year. Celltrion's US subsidiary is already in discussions with one major PBM over listing the SC formulation.

The company expects the intravenous formulation's listing across all three major PBMs to support negotiations for the SC formulation as well. Celltrion plans to tailor its sales strategy by channel — focusing on healthcare institutions for the IV formulation and pharmacies for the SC formulation — to maximize results.

Stoboclo-Osenvelt (denosumab), a bone disease treatment, has also been listed as a preferred drug on the public-insurance formulary of Express Scripts, one of the three major PBMs, with reimbursement in effect since the first quarter. Having already secured listings on CVS's private-insurance formulary and Optum's public- and private-insurance formularies, Stoboclo-Osenvelt has now covered most of the reimbursement territory held by the three major PBMs with the addition of the Express Scripts public-insurance listing. The company also plans to pursue the "open market," which accounts for roughly 30 percent of the US denosumab market, building on its expanded PBM reimbursement footprint.

Securing formulary listings and patient reimbursement from major PBMs — the critical gatekeepers of US pharmaceutical distribution — is considered a decisive milestone that drives a sharp increase in actual prescription volumes and underpins direct-sales profitability within the US private-insurance system. As the reimbursement base for Celltrion's high-margin products expands in the world's largest pharmaceutical market, the company's earnings growth is expected to gain further momentum.

"Our newly launched high-margin products in the US have secured consecutive listings on major PBM formularies, building brand credibility and reimbursement coverage at the same time," a Celltrion official said. "From the second half, when reimbursement kicks into full gear, we expect sales in the US market to accelerate and the upward earnings trend to continue."