Celltrion's Truxima Ranks No. 1 in U.S. Market Share, Surpassing Original and Competing Products

35.8% Market Share Achieved in February This Year

Truxima (ingredient: rituximab), a blood cancer treatment developed by Celltrion, has become the first biosimilar developed in Korea to reach the number one market share by prescriptions in the United States, the world’s largest pharmaceutical market.

According to pharmaceutical market research firm IQVIA on April 7, Truxima achieved a 35.8% market share (by prescription volume) in the United States as of February this year, claiming the top spot. This milestone, achieved about six years and three months after entering the U.S. market in November 2019, marks Truxima as the most prescribed rituximab product in the U.S., surpassing competing products.

Truxima, a blood cancer treatment developed by Celltrion. Celltrion

With this achievement, Truxima has earned the distinction of being the first Korean biosimilar to reach the number one market share in the United States, competing against original drugs and major global pharmaceutical products. This is seen as a landmark accomplishment that presents a vision and direction for other Korean bio-pharmaceutical companies, as it proves the potential for Korean companies to succeed in the U.S. market.

Truxima’s success is also reflected in its sales figures. Last year, Truxima recorded more than 300 billion won in sales in North America, including the United States, representing over 40% year-on-year growth and establishing itself as a core revenue source for Celltrion.

This achievement is particularly noteworthy as it comes at a time when the impact of U.S. pharmaceutical tariff policies on Celltrion’s business has effectively been resolved, and further business opportunities are anticipated. The U.S. government has excluded biosimilars, which account for most of Celltrion’s U.S. sales, from tariff application. Additionally, Zympentra (the U.S. product name for Remsima SC), currently being sold as a new drug in the United States, is also scheduled to be produced at the Branchburg plant, meaning it will also be unaffected by tariffs.

Meanwhile, Celltrion’s flagship autoimmune disease treatment, Inflectra (ingredient: infliximab, U.S. product name for Remsima), also recorded the highest prescription volume among biosimilars in the U.S. with a market share of 30.5%. Marking its tenth anniversary in the U.S. market since its launch in November 2016, Inflectra has maintained a stable market share of over 30% each year, solidifying its status as a global blockbuster drug. Furthermore, Zympentra’s prescription volume in January this year increased more than threefold compared to the previous year, indicating robust growth and accelerating synergy between the two products.

Aerial view of Celltrion Plant 2 in Songdo, Yeonsu-gu, Incheon. / Incheon – Photo by Hyunmin Kim

While existing flagship products continue to achieve stable sales in the U.S. market, newly launched high-margin product lines are also expanding their performance through increased market share and broader reimbursement coverage.

In particular, Stekima (ingredient: ustekinumab), an autoimmune disease treatment launched in March last year, achieved a market share of 10.2%, ranking among the leading biosimilars by prescription volume. Its inclusion as a preferred drug in the formularies of the three largest U.S. pharmacy benefit managers (PBMs) as well as major public and private insurance formularies in the top five PBMs, securing reimbursement coverage for more than half of patients, has driven this growth.

Aptozuma (ingredient: tocilizumab) and Stoboclo-Ocenbelt (ingredient: denosumab), both launched in the U.S. in the second half of last year, have also signed contracts with major PBMs and formularies, continuing to expand their reimbursement coverage. In addition, the subcutaneous formulation (SC) of Aptozuma and Omriclo (ingredient: omalizumab) are scheduled for launch in the U.S. market this year, which is expected to further strengthen the high-margin product portfolio and accelerate sales growth.

A Celltrion official stated, “With Truxima surpassing both original drugs and competitors to claim the top prescription market share in the U.S., its product awareness and preference will further improve. Both new and established products are continuing to show remarkable performance globally, including in the United States, and we expect to successfully achieve the company’s performance goals set for this year.”

This content was produced with the assistance of AI translation services.