Celltrion said Tuesday that it will present new data in the US showing that its biosimilar drug Truxima is comparable to Roche’s Rituxan in terms of efficacy, pharmacodynamics and safety, citing the conditions of rheumatoid arthritis patients who have switched to Truxima in place of the reference drug.

The clinical findings will be presented at the 2017 American College of Rheumatology Annual Meeting in San Diego, California, on Tuesday, local time.

A total of 295 patients participated in the extension period of the phase 3 clinical trials after being treated for up to 48 weeks with Truxima or Rituxan. During this extended period, patients treated with Rituxan either maintained or were switched to Truxima, and were observed for 24 weeks, according to the company.


The results showed that patients in both groups demonstrated equivalent efficacy and similar pharmacokinetic and safety profiles, said the South Korea-based drugmaker.

In April, Celltrion launched Truxima in Europe as the first Rituxan biosimilar approved by the European Medicines Agency. Truxima is also pending approval by the US Food and Drug Administration, which accepted the drug for review in July.

Based in Songdo of Korea, Celltrion specializes in the development of biosimilars referencing blockbuster biologic drugs including Remicade, Rituxan and Herceptin.

By Sohn Ji-young (jys@heraldcorp.com)