Celltrion (068270.KS) is expected to accelerate its business expansion in the United States, bolstered by regulatory reforms from the Centers for Medicare and Medicaid Services (CMS). The changes have created a favorable environment for expanding prescriptions of its flagship products, including Zymfentra and biosimilars.
According to the pharmaceutical and biotech industry on Wednesday, CMS recently finalized regulatory reforms that will raise Medicare Advantage (MA) insurer contributions by 2.48% starting in 2027 and increase the annual patient out-of-pocket maximum from $2,100 to $2,400. The reforms also include strengthening insurance processing standards from simply matching disease codes to thoroughly examining medical evidence.
"Cost reduction" is expected to emerge as the dominant theme in the U.S. healthcare market following these measures. Insurers will have no choice but to increase adoption of lower-priced biosimilars instead of expensive original drugs to offset their increased contribution burden. Patients facing higher out-of-pocket thresholds are also likely to turn to more price-competitive medications.
Celltrion's flagship product Zymfentra (Remsima SC) is expected to benefit directly from these changes. As U.S. authorities tighten medical review standards, the economic advantages of Zymfentra—a subcutaneous (SC) formulation that patients can self-administer at home—are expected to become more pronounced compared to intravenous (IV) treatments that require hospital visits and administration costs.
Having already secured pricing negotiation power through its local direct sales distribution network, Celltrion plans to use these regulatory changes as leverage to accelerate market share expansion in the United States. The exclusion of biosimilars from the recently announced U.S. administration's pharmaceutical tariff policy is also cited as a positive factor.
"The interests of the government, insurers, and patients are all aligned with biosimilar expansion," a Celltrion official said. "We will actively utilize our local direct sales system to drive prescription growth in the United States this year."