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Phase III switching data support long-term efficacy and safety of rituximab biosimilar Truxima Posted 10/11/2017

Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) rituximab biosimilar (Truxima, CT-P10) is comparable to Roche’s MabThera/Rituxan, according to the South Korean biotechnology company.

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

The phase III extension of the randomized controlled trial included 295 patients with rheumatoid arthritis (RA) who had completed treatment of up to 48 weeks with CT‑P10 or reference rituximab. It examined whether CT-P10 is comparable to reference infliximab as determined by the Disease Activity Score for 28 joints‑C‑Reactive Protein (DAS28‑CRP) improvement, as well as American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) response rates.

The results were presented at the 2017 American College of Rheumatology (ACR) Annual Meeting, which was held on 3−8 November 2017 in San Diego, CA, USA.

According to Celltrion, ‘CT-P10 showed long term effectiveness and tolerability throughout, and the DAS28‑CRP improvement, ACR and EULAR response rates, all clinically recognised measurements of efficacy, were comparable between patients switched to CT-P10 and those in the maintained group.’

Man Hoon Kim, President and CEO of Celltrion Healthcare, said that ‘the study shows the comparability of our biosimilar rituximab, CT-P10, to the reference rituximab after switching over a sustained period of time.’

Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.

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Source: Celltrion

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