Celltrion's Truxima Maintains No.1 Market Share in U.S. for 4 Consecutive Months...Also Achieves Interchangeability Status

Truxima Achieves 38.6% U.S. Market Share in May
First Rituximab Biosimilar to Obtain "Interchangeability"
Stekyma and Other Key Products Maintain Strong U.S. Sales

Celltrion's blood cancer treatment Truxima (ingredient name: rituximab) has maintained the top spot in prescriptions in the United States for four consecutive months. Earlier this month, Truxima also received interchangeability status from the U.S. Food and Drug Administration (FDA), becoming the first rituximab biosimilar to achieve this designation.

Celltrion's blood cancer treatment 'Truxima'. Celltrion

According to pharmaceutical market research firm IQVIA on July 21, Truxima reached a prescription share of 38.6% in the U.S. in May, ranking first. Compared to February, when it first claimed the top spot, its market share increased by 2.8 percentage points, widening the gap with competitor products, including the original drug. Truxima is the first Korean biosimilar product to become the market leader in the United States.

Earlier this month, Celltrion announced that Truxima was the first rituximab biosimilar to obtain interchangeability status from the FDA, allowing it to be substituted for the original drug. The company explained this would enable Truxima to further expand its penetration in the market segment, where the original product currently holds a market share in the 20% range.

During the same period, Celltrion's other major products also maintained their U.S. market share. Inflectra (ingredient name: infliximab, sold as Remsima in Korea), the company's autoimmune disease treatment, held a top position with a market share of 30.4%, while Stekyma (ustekinumab), Vegzelma (bevacizumab), and Yuflyma (adalimumab) had market shares of 13.3%, 10.6%, and 8.1% respectively.

Celltrion's U.S. subsidiary plans to launch Aptozma (tocilizumab) in a subcutaneous (SC) formulation and Omriclo (omalizumab) in the second half of this year. The company intends to utilize its existing prescription benefit manager (PBM) network—established through sales of current products—to ensure a successful market launch for these new products.

Meanwhile, Celltrion announced through a regulatory filing that its consolidated sales for the second quarter of this year reached 1.3 trillion won, with an operating profit of 430 billion won. These figures represent the highest second-quarter performance in the company’s history.

A Celltrion representative stated, "Building on the strong sales performance of our main products, including Truxima, we will do our utmost to ensure that our highly profitable follow-up products scheduled for launch in the second half of the year quickly capture the U.S. market as well."

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