The results of phase III quality of life (QoL) assessments of a candidate biosimilar infliximab (CT-P13) have shown the comparability of the biosimilar (CT-P13) and its reference product, Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).
South Korean biotechnology company Celltrion presented the results of the study 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 [1].
In the phase III, randomized, double-blind, active-controlled study 606 patients with rheumatoid arthritis were treated for up to one year with either biosimilar infliximab (CT-P13) or Remicade. Participants received 3 mg/kg intravenous doses of CT-P13 or Remicade over 2 hours at Week 0, Week 2, Week 6 and then every 8 weeks up to Week 54.
Evaluation of QoL was based on the standard Health Assessment Questionnaire (HAQ)-disability index and the Short Form (36) Health Survey (SF-36). The HAQ assessment of physical function measures 20 items in eight categories on a scale from 0 (without any difficulty) to 3 (unable to do). The SF-36 assesses eight subscales, a low score representing poor health status.
Baselines were similar between treatment groups. Early overall improvement as measured by a reduction in the HAQ scores was evident and similar in magnitude between biosimilar infliximab (CT-P13) and Remicade by Week 14. In addition, changes over time were similar between the two treatment groups and the effectiveness of CT-P13 and Remicade was sustained over the one-year interval.
Treatment with both biosimilar infliximab (CT-P13) and Remicade improved physical function as assessed by HAQ in patients with moderate to severe physical disability and this was sustained over a one-year interval. Celltrion therefore concluded that these data support the comparability with respect to improvement in physical function of CT-P13 and Remicade in patients with active rheumatoid arthritis.
Celltrion received approval from the European Medicines Agency (EMA) for its monoclonal antibody Remsima (infliximab) on 10 September 2013 [2, 3]. Remsima 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.
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. Yoo DH, et al. Impact of CT-P13 and originator infliximab treatment on quality of life derived from the Health Assessment Questionnaire (HAQ) and Short-Form 36 (SF-36) from a randomized, double-blind trial in patients with active RA. American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting, San Diego, US, 26-30 October 2013. Abstract:#2392.
2. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 10]. 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 2014 Jan 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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