Celltrion Healthcare, the marketing arm of biosimilar maker Celltrion, on Nov. 6 unveiled new data showing Truxima is comparable to Roche’s Rituxan in terms of efficacy, pharmacodynamics and safety profile, over a sustained period of time after switching from the reference drug in patients with rheumatoid arthritis.
The company presented the phase 3 switching data at the 2017 American College of Rheumatology Annual Meeting.
A total of 295 patients participated in the extension period of the phase 3 clinical trials after completing treatment for up to 48 weeks with Truxima or Rituxan. Patients with rheumatoid arthritis in both groups during this main period demonstrated equivalent efficacy and similar pharmacokinetic and safety profiles.
Celltrion Healthcare brought Truxima to the European Union in April as the first ever Rituxan biosimilar that was approved by the European Commission in February while it applied for approval by the US Food and Drug Administration in June.
“In the field of rheumatology, whether to switch patients to biosimilars is a pressing question among physicians. Therefore, it is important to see results from studies such as this, which shows comparable long-term efficacy and safety of Truxima, a biosimilar for Rituxan following switching,” said Rieki Alten, director of the Rheumatology Research Centre at the Teaching Hospital of the Charité, Berlin, Germany.
Truxima is approved in the EU for treatment of patients with Non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.
By Park Han-na (email@example.com