US-based biologicals company Epirus Biopharmaceuticals (Epirus) announced on 9 February 2016 that it had started a phase III trial for its infliximab biosimilar (BOW015).
The global clinical trial is designed to compare the safety, efficacy and immunogenicity of BOW015 versus blockbuster arthritis drug Remicade (infliximab) in patients with active rheumatoid arthritis despite methotrexate therapy. The trial is a prospective, randomized, double-blind, parallel group, multicentre, global, phase III clinical study.
The main objective of the study is to compare the American College of Rheumatology (ACR) 20 clinical response of BOW015 and Remicade over a 16-week period. Secondary objectives include comparison of the ACR20 response over 54 weeks, as well as Diseases Activity Score (DAS)28 calculated with C-reactive protein (CRP) and Health Assessment Questionnaire-Disability Index (HAQ-DI). The UNIFORM trial will include 548 patients aged 18 to 80 years and will be conducted at sites in Europe, North America and Latin America. The trial is expected to be completed by July 2017.
Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.
The originator product, Johnson & Johnson and Merck’s Remicade (infliximab) had worldwide sales of US$9.3 billion in 2014, making it the world’s best-selling medicine and a lucrative target for biosimilars developers. The patents on Remicade expired in Europe in February 2015 and will expire in the US in September 2018 [1].
Epirus’ partner, India-based Ranbaxy Laboratories (Ranbaxy), launched the infliximab ‘similar biologic’ BOW015 in India in December 2014 [2].
Editor’s comment
It should be noted that ‘similar biologics’ approved in India 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. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. First infliximab ‘similar biologic’ launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Biosimilars/News/First-infliximab-similar-biologic-launched-in-India
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Source: ClinicalTrials.gov
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