Truxima (CT‑P10) was approved by the European Commission (EC) in February 2017 for all the indications of the reference biological, Roche’s MabThera/Rituxan (rituximab), in the European Union (EU). These include treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis [2]. The EU approval was based on clinical trials carried out in rheumatoid arthritis patients [3].

In this study, 121 patients with AFL were randomly assigned to receive an infusion (375 mg/m²) of either CT‑P10 (n = 59) or rituximab (n = 62), at a 3-week interval, in combination with CVP.

The pharmacokinetic analysis was conducted in terms of AUC_tau and C_max at steady state and at 12 weeks (Core Cycle 4) and proved to be ‘highly similar for the two treatment groups’. The B-cell kinetics was also similar up to Core Cycle 4 in the two treatment groups. The proportion of patients with positive anti-drug antibodies up to Core Cycle 4 at post-treatment visits was similar between the two treatment groups; 3/59 (5.1%) and 2/62 (3.2%) of patients in the CT‑P10 and rituximab groups, respectively. In addition, CT‑P10 was well tolerated and the safety profile of CT‑P10 up to Core Cycle 4 was similar to that of rituximab.

The authors therefore concluded that the ‘study demonstrated similarity of PK in terms of AUC_tau and C_maxSS between CT‑P10 and rituximab in AFL patients. The B‑cell kinetics and immunogenicity were comparable between the two treatment groups.’ And finally, ‘CT‑P10 was well tolerated with a safety profile comparable to that of rituximab up to and including Core Cycle 4 (12 weeks)’.

Celltrion’s Truxima is the first cancer biosimilar approved in the EU, although others are hot on their heels. Sandoz submitted its rituximab biosimilar (GP2013) to the European Medicines Agency (EMA) in May 2016. Pfizer is carrying out a phase I/II trial in rheumatoid arthritis and phase III trial in lymphoma for its rituximab biosimilars (PF‑05280586). Mabion and Mylan are also carrying out a phase III trial in lymphoma for their rituximab biosimilar (MabionCD20). In addition, Amgen is also reported to be developing a rituximab biosimilar (ABP 798), and Taiwan-based JHL Biotech reported the dosing of its first patient in the European trial of its rituximab biosimilar (JHL1101) [4].

Related article
Biosimilar rituximab in biological naïve rheumatoid arthritis patients

References
1. Bertrand C, et al. Pharmacokinetic and safety of CT-P10, a biosimilar candidate to the rituximab reference product, in patients with newly diagnosed advanced stage follicular lymphoma (AFL). Blood. 2016;128(22):1807.
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for first cancer biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 21]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-first-cancer-biosimilar-Truxima
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar rituximab approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 21]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-South-Korea
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-rituximab

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