Celltrion's Truxima shows safety, efficacy in post-marketing study

South Korean biopharmaceutical company Celltrion Inc. reported on Wednesday that its biosimilar drug Truxima (rituximab), a generic version of Roche Holding AG's cancer drug Rituxan, has shown safety and efficacy in a post-marketing study involving 677 patients in Korea.

The study, published in the journal Expert Opinion on Biological Therapy, evaluated Truxima's use for several indications, including non-Hodgkin's lymphoma, rheumatoid arthritis, chronic lymphocytic leukemia, Wegener's granulomatosis, and microscopic polyangiitis.

The study found that Truxima had a similar safety profile and high response rate as the original drug based on data from 27 Korean centers between Nov. 2016 and Nov. 2020.

"We hope that these study results will serve as meaningful evidence for expanding the prescription of Truxima," said a Celltrion official. "We will continue to analyze the post-marketing clinical data and strive to provide patients with high-quality medicines."

Containing the active ingredient rituximab, Truxima was approved for sale in Korea in 2016, later receiving regulatory approvals in Europe and the US in 2017 and 2018, respectively.

The drug has been gaining market share in both regions, reaching 23.6% in Europe and 27.6% in the US as of the third quarter of 2022, according to Celltrion. The global market size of rituximab was estimated at $5.9 billion in 2021 by pharmaceutical market research company IQVIA.

Write to Jeong-Min Nam at peux@hankyung.com