Celltrion’s hematologic cancer treatment is consolidating its leading position in the United States, the world’s largest market.

Celltrion announced on the 21st that “Truxima” (ingredient name: rituximab) has ranked No. 1 in market share in the United States for four consecutive months.

According to data compiled by pharmaceutical market research firm IQVIA, Truxima recorded a 38.6% market share in the U.S. in May, maintaining the top prescribing position for four consecutive months since February. In particular, its recent share rose by 2.8 percentage points compared with February, when it first took the No. 1 spot, widening the gap in the overall rituximab prescription market, including the originator product, and maintaining market leadership.

A Celltrion official stated, “Truxima is a milestone medicine as it is the first domestically developed biosimilar to capture the No. 1 market share in the United States,” adding, “By surpassing leading global big pharma companies to achieve the top share in the U.S., which accounts for half of the global pharmaceutical market, it has highlighted the advancement and technological capabilities of Korea’s pharmaceutical and bio industry.”

Truxima’s growth trajectory in the U.S. is expected to continue for some time. Earlier this month, it became the first rituximab biosimilar to obtain “interchangeability” status from the U.S. Food and Drug Administration (FDA), which allows substitution with the originator product. This is seen as securing an additional growth driver in the U.S. market. Once interchangeability status is granted, pharmacies can substitute the originator product with the biosimilar for prescribing and dispensing without a change in the physician’s prescription. From the patient’s perspective, this enables access to a medicine with the same efficacy as the originator at a lower cost.

Based on Truxima’s interchangeability status, Celltrion expects penetration into the roughly 20% market segment still held by the originator product to accelerate further.

Other Celltrion products are also showing growth. Its flagship autoimmune disease treatment “Inflectra” (ingredient name: infliximab; U.S. product name: Remsima) maintains a leading position in the U.S. with a 30.4% market share. Steqima (ustekinumab), Vegzelma (bevacizumab), and Yuflyma (adalimumab) are continuing stable performance, with market shares of 13.3%, 10.6%, and 8.1%, respectively. Preparations for the launch of follow-on products are also progressing smoothly. Celltrion’s U.S. subsidiary plans to launch Aptozma (tocilizumab) in a subcutaneous (SC) formulation and Omviclo (omalizumab) in the second half of this year. The company intends to actively leverage the large pharmacy benefit manager (PBM) network it has built while selling its autoimmune disease portfolio to help new products establish themselves in the market.

A Celltrion official said, “As Truxima and other key products have all achieved remarkable results in the United States, expectations for growth in the second half of the year are rising,” adding, “We will make every effort to secure an early foothold in the U.S. market for the high-margin follow-on products scheduled for launch in the second half.”

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