Celltrion (068270.KS) expects to accelerate its U.S. business expansion, buoyed by regulatory reforms from the Centers for Medicare & Medicaid Services (CMS). The company sees a more favorable environment for broader adoption of its flagship products, including Zymfentra and its biosimilar portfolio.
Celltrion said Wednesday that new Medicare policies from U.S. health authorities have created greater growth opportunities for its directly marketed products and key product lines in the United States. The revised plan includes a 2.48% increase in insurer premiums for Medicare Advantage (MA) plans, adjustments to patient out-of-pocket cost caps, and strengthened government oversight of healthcare utilization. Celltrion believes these regulatory changes will help expand prescriptions for biosimilars, which offer relatively stronger price competitiveness, and for Zymfentra, which allows self-administration.
Starting in 2027, insurers operating MA plans — in which private insurers manage Medicare coverage for senior citizens — will face higher premium obligations. This is likely to make insurers favor lower-priced medications. Celltrion expects biosimilar adoption to expand further through this process.
The patient out-of-pocket cost cap will also rise from $2,100 in 2026 to $2,400 in 2027. As patients face a greater cost burden, demand for competitively priced medications could increase, analysts say. Celltrion expects this shift to accelerate prescriptions for its biosimilar product lineup.
Strengthened government oversight of healthcare utilization is also seen as a favorable factor for Zymfentra. Zymfentra is the U.S. brand name for Celltrion's autoimmune disease treatment Remsima SC, a subcutaneous (SC) formulation that patients can self-administer without hospital visits. U.S. government and regulatory authorities plan to shift from diagnosis code-based reimbursement decisions to medical evidence-based review standards. This change could highlight the cost burden of intravenous (IV) formulations, increasing preference for self-administered SC formulations. Celltrion projects that Zymfentra's adoption rate will rise accordingly.
Celltrion views the regulatory changes as aligned with the interests of insurers, patients, and manufacturers alike. Biosimilars can ease the government's fiscal burden through lower prices and proven efficacy compared to originator drugs, while also reducing costs for insurers and patients, the company explained.
The company emphasized that it has already established a local response system in the United States. Celltrion operates product manufacturing and supply chains locally and has secured a direct sales distribution network through its U.S. subsidiary, giving it both price competitiveness and negotiating leverage with insurers and pharmacy benefit managers (PBMs).
The U.S. administration's pharmaceutical tariff policy, announced the same day, was also assessed as a positive variable. Celltrion noted that with biosimilars — which account for a large share of its U.S. revenue — excluded from tariff targets, combined with the CMS policy promoting lower-cost drugs, its competitive position in the U.S. market will be further strengthened.
"This CMS policy clearly demonstrates the U.S. government's direction toward expanding the use of biosimilars and innovative formulation therapies," a Celltrion official said. "It has been reaffirmed that Zymfentra and our biosimilar product lineup are choices that align with this direction." The official added, "We will actively leverage the manufacturing and direct sales systems we have built in the U.S. to enhance competitiveness, and starting this year, we will accelerate prescription expansion and strengthen our market influence in the United States."