Celltrion said a favorable environment has formed in the U.S. market for expanding prescriptions of biosimilars due to changes in the administration's insurance policy.
The company said on the 6th (local time) that, under the "2027 Medicare Advantage (MA) rate and Part C and D payment policies" released by the U.S. Centers for Medicare and Medicaid Services (CMS), growth opportunities for its direct sales strategy and core product lineup will expand. Medicare is public insurance for older adults in the United States, and Medicaid is public insurance for low-income people.
The announcement includes: ▲ a 2.48% increase in MA plan insurers' financial responsibility ▲ a higher patient out-of-pocket maximum ($2,100 in 2026 → $2,400 in 2027) ▲ stronger government oversight of patient healthcare utilization. Overall, the changes are seen as favorable for expanding prescriptions of biosimilars and "Zymfentra" (the U.S. product name for Remsima SC).
The core is to "induce healthcare cost savings." The U.S. government has designed the system to expand the use of relatively lower-priced medicines in order to reduce the fiscal burden on insurance.
First, the burden on insurers operating MA plans will increase. Starting in 2027, as insurers' financial responsibility rises by 2.48%, incentives to prefer lower-priced biosimilars are expected to grow.
Patients' burden will also rise. As the annual out-of-pocket maximum increases from $2,100 to $2,400, the tendency to seek medicines with stronger price competitiveness is expected to strengthen.
The way healthcare utilization is managed will also change. It will shift from a disease code-centered approach to one that determines coverage based on actual treatment need and evidence. With additional costs incurred for intravenous (IV) administration also taken into account, subcutaneous (SC) formulations that allow self-administration are expected to be relatively advantageous.
These changes are expected to work positively for Celltrion's key product, "Zymfentra." Zymfentra is a subcutaneous formulation that patients can administer at home, reducing hospital visits and additional expense burdens.
Ultimately, as cost savings are important for insurers, patients and the government alike, biosimilars are emerging as a practical alternative. Based on lower prices than original medicines and proven efficacy, market adoption could accelerate.
Celltrion has already established a local framework to respond. In addition to production and supply in the United States, it operates a direct sales distribution network through its own subsidiary, which is seen as securing price competitiveness and bargaining power with insurers and pharmacy benefit managers (PBMs).
In particular, the direction aligns with the U.S. government's drug tariff policy released the same day. With biosimilars excluded from tariff application, the trend toward lowering healthcare costs has become clearer.
A Celltrion official said, "This CMS policy shows the U.S. government's direction to expand the use of competitive medicines," adding, "We will continue to expand prescriptions and strengthen our influence in the U.S. market, focusing on biosimilar products including Zymfentra."