Celltrion biosimilar proves effectiveness in lymphoma and rheumatoid arthritis
pharmafile | June 14, 2017 | News story | Research and Development | Cellltrion, Truxima, biosimilar, lymphoma, rheumatoid arthritis, rutiximab
Celltrion Healthcare has revealed new data which validates its biosimilar Truxima (CT-P10) as non-inferior to its reference product rituximab in the treatment of advanced follicular lymphoma (FL) and rheumatoid arthritis (RA).
The drug’s effectiveness in treating FL was shown through data presented at the International Conference on Malignant Lymphoma (ICML). In a Phase 3 study, 140 participants suffering from an untreated and advanced form of the disease were administered with Truxima in combination with standard chemotherapy of cyclophosphamide, vincristine and prednisone. It was found that the drug produced results comparable to its reference product rituximab; safety profile, pharmacokinetics, pharmacodynamics and immunogenicity were also comparable.
Additionally, data presented at the European League Against Rheumatism (EULAR) congress 2017 showed that no clinically significant differences were found in the effectiveness of Truxima in the treatment of 372 RA patients over 48 weeks.
“Our studies consistently demonstrate the equivalence and comparability of our biosimilar rituximab, CT-P10, to reference rituximab,” explained Dr Kwon, Medical Director at Celltrion Healthcare. “We are the only company that is able to proudly state that we have conducted Phase III clinical trials looking into the safety and efficacy of its biosimilar in two indications – rheumatoid arthritis and non-Hodgkin’s lymphoma, which is a testament to our commitment to providing quality biosimilar treatments for patients supported by robust clinical data.”
Dr Dae-Hyun Yoo, Global Principal Investigator of the RA study and Professor of Medicine at Hanyang University Hospital for Rheumatic Diseases at Hanyang University’s College of Medicine, added: “The data in support of CT-P10 are very encouraging, as it means that biosimilar rituximab could prove a reasonable therapeutic alternative to patients with rheumatoid arthritis who have a high BMI and have had an inadequate response to anti-TNFs.”
Matt Fellows
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