Targeted biological therapies have proven themselves highly effective in the treatment of inflammatory joint diseases, but their benefits are restricted by cost. Biosimilars of these therapies would offer affordable alternatives, but establishing biosimilarity presents many challenges, write Professors Jonathan Kay and Josef Smolen [1].
Professors Kay and Smolen’s editorial accompanies the results of the first randomized clinical trials of a biosimilar version of infliximab, CT-P13 [2]. The authors draw parallels between clinical trials to assess biosimilarity and a musician’s audition for a chair in a symphony orchestra. ‘In the interest of time’, they write, ‘the judges usually ask to hear only the specific challenging sections, rather than the instrumental part of the entire work’. In this case, the endpoint of the trial represents the most difficult passage in a musical score.
CT-P13 is South Korean biotechnology company Celltrion’s biosimilar version of Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab). Remicade is a chimeric monoclonal antibody approved by EMA in 1999 for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis and psoriatic arthritis.
The trials included a phase I study comparing the pharmacokinetics, efficacy and safety of CT-P13 with the originator infliximab, each as monotherapy for treating patients with ankylosing spondylitis; and a phase III study evaluating the efficacy and safety of CT-P13 compared with infliximab each in combination with methotrexate in patients with active rheumatoid arthritis.
The phase I study, PLANETAS, and the phase III study, PLANETRA, are the first clinical trials to demonstrate unequivocal efficacy of a biosimilar for the treatment of rheumatic disease indications. As a result, CT-P13 was approved in South Korea in 2012 and in Europe in 2013 [3, 4]. Although infliximab patents do not expire until September 2018 in the US and August 2014 in the EU [5], the launch of CT-P13 in other Eastern and Central European countries is underway [6].
These landmark studies will serve as the foundation for future clinical trials of biosimilars in patients with rheumatic diseases, conclude the authors.
Conflict of interest
The authors of the research paper [1] reported that they had provided expert advice to, participated in symposia for and/or received research grant support from originator and biosimilars companies.
Editor’s comment
Readers interested to learn more about biosimilar monoclonal antibodies are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Biosimilar monoclonal antibodies—challenges and opportunities in Europe
If you are interested in contributing a research paper in a similar area to the GaBI Journal, please send us your submission here.
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Biosimilar infliximab equivalence proven in phase III trial
References
1. Kay J, Smolen JS. Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis. 2013;72(10):1589-93.
2. GaBI Online - Generics and Biosimilars Initiative. Trials of biosimilar monoclonal antibody prove biosimilarity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 28]. Available from: www.gabionline.net/Biosimilars/News/Trials-of-biosimilar-monoclonal-antibody-prove-biosimilarity
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 28]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea
4. GaBI Online - Generics and Biosimilars Initiative. EMA approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 28]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-first-monoclonal-antibody-biosimilar
5. 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 2014 Feb 28]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
6. GaBI Online - Generics and Biosimilars Initiative. Alvogen launches infliximab biosimilar in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 28]. Available from: www.gabionline.net/Biosimilars/News/Alvogen-launches-infliximab-biosimilar-in-Europe
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