Polish biologicals company Mabion announced on 25 November 2014 that it had received the consent of the appropriate regulatory authorities in Croatia, Bosnia and Herzegovina, Serbia and Poland to start a phase III clinical trial for its rituximab biosimilar (MabionCD20) in patients with diffuse large B-cell lymphoma.
The trial will be carried out in collaboration with Croatia-based contract research organization Altiora, with whom Mabion is also carrying out a phase III trial of its rituximab biosimilar in patients with rheumatoid arthritis.
The lymphoma trial will be carried out in 140 patients and will evaluate the comparative bioequivalence of Mabion’s biosimilar rituximab (MabionCD20) compared to Roche’s MabThera/Rituxan (rituximab) in patients with CD20-positive diffuse large B-cell lymphoma.
The lymphoma trial is a multicentre, double-blind, randomized, active-controlled, two-arm study. Mabion plans to demonstrate a high level of biosimilarity between MabionCD20 and MabThera based on the percentage of patients achieving the primary pharmacokinetic endpoints. Secondary objectives for the trial include comparative analysis of pharmacodynamic parameters, pharmacokinetic parameters, the percentage of patients achieving the efficacy endpoints, comparative safety and immunogenicity. The trial will be carried out across 20 different sites in Bosnia and Herzegovina, Bulgaria, Croatia, Georgia, Hungary, Moldova, Poland and Serbia in patients, aged 18 years and above, and is expected to last one year and six months.
MabThera/Rituxan had sales of CHF7 billion during 2013. Therefore, it comes as no surprise that many companies are working on biosimilars of the drug. The patents on MabThera/Rituxan expire in the US in September 2016 and already expired in Europe in February 2013 [1]. Companies with biosimilars in the pipeline include Boehringer Ingelheim, Gedeon Richter, Sandoz (the generics division of Novartis) and Stada Arzneimittel [2].
In April 2014, Russian biotechnology company Biocad announced that the Russian Ministry of Health had approved the company’s non-originator rituximab drug, AcellBia (BCD-20) [3].
Mabion intends to market its rituximab biosimilar in all global markets where MabThera is sold. To this end, the company plans to market the biosimilar in the European Union ‘on its own’ and already has agreements in place for Iceland, Eastern Europe, Turkey, South America and North Africa. It has also signed a letter of intent with Regulatory Compliance Associates, which provides comprehensive solutions for regulation and compliance with the requirements of the US Food and Drug Administration.
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References
1. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
2. GaBI Online - Generics and Biosimilars Initiative. Sandoz’s biosimilar rituximab on track [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-s-biosimilar-rituximab-on-track
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar rituximab approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-Russia
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Source: EU Clinical Trials Regsiter, Mabion
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