The results of two open-label extension studies of Inflectra (CT-P13; infliximab), one in patients with rheumatoid arthritis, the other in patients with ankylosing spondylitis, have confirmed the similarity, with respect to efficacy and safety, of the biosimilar infliximab and its reference product, Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).
Hospira presented the results of the studies at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego, USA, which was held on 26–30 October 2013.
The objective of these open-label extension studies was to confirm the long-term efficacy and safety of Inflectra in patients who had completed the original 54-week European Union (EU) clinical studies and to investigate switching from the reference Remicade product to Inflectra.
In the study in patients with rheumatoid arthritis, 302 of 455 patients who completed the phase III PLANETRA study were entered into the open-label extension phase. Of these, 158 were continuously treated with Inflectra (maintenance group) and 144 were switched from Remicade to Inflectra (switch group) for one additional year. The maintenance group and the switch group at weeks 78 and 102 were similar as measured by ACR20/50/70, Disease Activity Score (DAS 28-CRP [Disease Activity Score 28-C-Reactive Protein], DAS 28-ESR [Disease Activity Score 28-Erythrocyte Sedimentation Rate]), European League Against Rheumatism (EULAR-CRP [The European League Against Rheumatism-C-Reactive Protein], EULAR-ESR [The European League Against Rheumatism-Erythrocyte Sedimentation Rate]) response rates. Overall incidence of treatment-emergent adverse events was similar in both groups.
In the study in patients with ankylosing spondylitis, 174 of 210 patients who completed the phase I PLANETAS study entered into the open-label extension phase. Of these, 88 were continuously treated with Inflectra (maintenance group) and 86 were switched from Remicade to Inflectra (switch group) for one additional year. The maintenance group and the switch group at weeks 78 and 102 were similar as measured by Assessment in Ankylosing Spondylitis (ASAS20)/ASAS40, ASAS partial remission and Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP rates. In this study, the adverse event profile for CT-P13 was generally consistent with the originator.
Hospira made an agreement with South Korean biotechnology company Celltrion back in 2009 to carry out research into eight monoclonal antibodies including arthritis treatment infliximab and cancer drug trastuzumab [1]. The monoclonal antibody Inflectra received approved from the European Medicines Agency (EMA) on 10 September 2013 [2, 3]. Inflectra has been approved for use in the same indications as Remicade, i.e. for the treatment of inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.
Hospira’s deal with Celltrion gives Hospira the rights to market Inflectra in Australia, Canada, Europe, New Zealand, United States, as well as in certain Commonwealth of Independent States (CIS) countries. The biosimilar will also be marketed by Celltrion as Remsima.
According to its press release, Hospira intends to launch Inflectra throughout Europe at the earliest opportunity taking into account any relevant patent protection. The patent on Remicade was due to expire in Europe in August 2014, but Johnson & Johnson recently gained a paediatric extension, staving off competition from biosimilars until February 2015 [2].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Hospira looks to biosimilars and increased use of generics for growth [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 22]. Available from: www.gabionline.net/Biosimilars/News/Hospira-looks-to-biosimilars-and-increased-use-of-generics-for-growth
2. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 22]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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