Biologicals major Amgen is carrying out a global phase III clinical trial for a biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).
The study will evaluate the pharmacokinetic (PK) similarity of Amgen’s biosimilar rituximab (ABP 798) versus Roche’s MabThera/Rituxan in patients with rheumatoid arthritis.
The trial is a multicentre, double-blind, randomized, active controlled, three-arm study. Amgen plans to evaluate the pharmacokinetic (PK) similarity of ABP 798 following two intravenous infusions of 1,000 mg each compared with MabThera/Rituxan (rituxan EU/US) in 300 patients with rheumatoid arthritis. Secondary objectives for the trial include an assessment of the efficacy and safety of ABP 798 compared to MabThera/Rituxan. The trial will be carried out across 41 different sites in Belgium, Bulgaria, Canada, Czech Republic, Estonia, France, Germany, Hungary, The Netherlands, Poland, Spain and the US, in patients aged 18 years and above, and is expected to last two years and two months.
MabThera/Rituxan had global sales of Euros 8.6 billion during 2013 [1]. Therefore, it comes as no surprise that, despite the fact that the patent on rituximab does not expire until 2018 in the US, many companies are working on biosimilars of the drug. 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 rituximab non-originator biological, AcellBia (BCD-20) [3].
Rituximab is not the only biosimilar that Amgen has in its sights. The company is also currently conducting two phase III clinical trials for a biosimilar version of AbbVie’s blockbuster autoimmune disease treatment Humira (adalimumab) [4, 5].
Editor’s comment
It should be noted that ‘non-originator biologicals’ approved in Russia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Top 8 blockbuster biologicals 2013 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/General/Top-8-blockbuster-biologicals-2013
2. GaBI Online - Generics and Biosimilars Initiative. Sandoz’s biosimilar rituximab on track [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. 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 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-Russia
4. GaBI Online - Generics and Biosimilars Initiative. Amgen to start phase III trial for biosimilar adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/News/Amgen-to-start-phase-III-trial-for-biosimilar-adalimumab
5. GaBI Online - Generics and Biosimilars Initiative. Amgen starts another phase III trial for biosimilar adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/News/Amgen-starts-another-phase-III-trial-for-biosimilar-adalimumab
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Source: EU Clinical Trials Register
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