Celltrion is expected to gain fresh growth momentum in the U.S. market following recent changes to Medicare policies that are seen as favorable to biosimilars and cost-efficient therapies.
The company said the latest policy updates announced by the U.S. Centers for Medicare & Medicaid Services (CMS) for 2027—including Medicare Advantage (MA) rates and Part C and D payment policies—are likely to create a more supportive environment for expanding prescriptions of its biosimilars and key products.
The revised framework introduces structural changes such as increased insurer cost burdens, higher out-of-pocket limits for patients, and stricter utilization management. Under the MA plans, insurer contributions are set to rise by 2.48%, which is expected to encourage greater adoption of lower-cost treatment options, including biosimilars.
The annual out-of-pocket cap for patients will also increase from $2,100 in 2026 to $2,400 in 2027. As patients face higher direct costs, demand for more affordable medications is likely to grow, potentially supporting wider prescription of Celltrion’s portfolio.
In addition, tighter utilization management standards are expected to shift evaluation criteria from diagnosis-based coding toward evidence-based medical necessity. This change is likely to emphasize both treatment efficiency and cost considerations. In this context, subcutaneous (SC) formulations—allowing for self-administration and avoiding additional costs associated with intravenous (IV) treatments—are expected to gain traction. Celltrion’s self-injectable therapy Zymfentra is seen as a potential beneficiary of this trend.
Industry analysts suggest that biosimilars could emerge as a key solution to reduce healthcare costs for insurers, patients, and governments alike under the new policy environment. With competitive pricing and clinically validated efficacy, biosimilars are expected to see higher adoption and preference rates.
Celltrion has already established local manufacturing and supply systems in the U.S., along with a direct sales and distribution network, enabling it to respond quickly to policy changes. This infrastructure is also strengthening its negotiating position with insurers and pharmacy benefit managers (PBMs).
Meanwhile, the U.S. government’s decision to exclude biosimilars from pharmaceutical tariffs is expected to further support cost reduction efforts and reinforce demand for affordable therapies. Combined with CMS policy changes, these measures are likely to expand the market for cost-effective drugs, potentially increasing Celltrion’s market influence.
Celltrion said it plans to accelerate prescription growth in the U.S. by leveraging its local production and direct sales capabilities, while continuing to strengthen its global competitiveness over the long term.
