Celltrion is eyeing an expansion of its biosimilar business following changes to U.S. Medicare policies. The company expects a growing preference for lower-cost medications as both insurers and patients face increasing financial pressure.
Celltrion announced on Wednesday that the U.S. Centers for Medicare & Medicaid Services (CMS) has created a favorable landscape for expanding the prescribing of its biosimilars, including Zymfentra (marketed as Remsima SC in the U.S.), under the newly released 2027 Medicare Advantage (MA) and Parts C & D payment policies.
Key changes in the policy include a 2.48% increase in costs for MA plan insurers, a rise in patient out-of-pocket maximums from $2,100 to $2,400, and tighter controls on medical utilization. The company said these shifts are likely to push both insurers and patients toward more cost-effective medication options.
For insurers, using lower-priced drugs offers an opportunity to reduce overall expenses, creating stronger incentives to adopt biosimilars. Similarly, patients are expected to shift toward more affordable treatment options as their out-of-pocket costs increase.
Enhanced management of medical utilization is also expected to benefit Celltrion. As reimbursement criteria shift from a disease code-based approach to an evidence-based model, the additional costs associated with intravenous (IV) formulations may become more apparent. This could increase the appeal of subcutaneous (SC) formulations that allow for self-administration. As a result, the company expects an increase in Zymfentra adoption.
Celltrion highlighted its competitive edge, noting that it operates both local production facilities and direct sales distribution channels in the U.S. This dual approach improves price competitiveness and strengthens its negotiating position with insurers and pharmacy benefit managers (PBMs). The company also cited its ability to respond quickly to policy changes as a key advantage.
Celltrion also sees alignment between its strategy and the U.S. government’s recently announced pharmaceutical tariff policy. The exemption of biosimilars from tariffs is expected to support broader efforts to reduce healthcare costs.
A Celltrion spokesperson said the CMS policy signals the U.S. government’s intent to expand the use of cost-competitive medications, adding that the company’s biosimilar portfolio, including Zymfentra, is well-positioned in the current market environment.
The spokesperson added that Celltrion plans to leverage its established local production and direct sales system to strengthen competitiveness and expand prescriptions, while reinforcing its market presence in the U.S. starting this year.
