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Post-marketing experience with IBD biosimilars Posted 19/05/2017

The introduction of anti-tumour necrosis factor-alpha (TNF-α) monoclonal antibodies (mAbs), about two decades ago, has revolutionized the management of inflammatory bowel disease (IBD). However, they are also expensive and their cost can lead to restricted access for many patients.

Infliximab was the first anti-TNF-α agent to be used and the first to lose patent protection and Celltrion’s CT-P13 was the first infliximab biosimilar to be available. The clinical trial programme to demonstrate biosimilarity between CT-P13 and reference infliximab consisted of a phase I pharmacokinetic study in patients with ankylosing spondylitis (AS) and a phase III study evaluating efficacy in patients with rheumatoid arthritis (RA). Both were randomized, double-blind, multi-national trials with 30 weeks of treatment. More recently, data up to 54 weeks with a subsequent open-label, 48-week extension, in which patients initially receiving reference infliximab were switched to CT-P13, have been published. All these studies have demonstrated pharmacokinetic equivalence and clinical efficacy in both AS and RA up to 102 weeks, also after switching from infliximab.

Based on extensive in vitro characterization through a comparability exercise and initial clinical data, the indications of CT-P13 have been extended since 2013 by the European Medicines Agency (EMA) and more recently by the US Food and Drug Administration (FDA) and Health Canada, to include IBD [1]. Because of the lack of a published controlled trial on the efficacy and safety of CT-P13 in IBD, some concerns were initially raised by medical societies and expert opinion editorials. However, progressive updates of the scientific literature that included real-life data have been reassuring in terms of efficacy and safety, also after switching and in the paediatric setting. Although it should be noted that follow up is still limited.

In this review, the authors evaluated the available open label case series of IBD patients treated with CT-P13 across the world [2]. More than 600 IBD patients were evaluated, 39 paediatric patients and 183 switched from infliximab. In most cases, only a clinical evaluation was performed. The mean efficacy was 72%, the rate of adverse events 10.4%, and the rate of infusion reactions was 5.5%. These findings are very much comparable to the experience with infliximab. Data from the controlled trials NOR-SWITCH (NCT02148640) [3], SIMILAR (NCT02452151) and CT-P13 (NCT02096861) are also expected to provide evidence regarding the switching, efficacy and safety of biosimilar infliximab.

More recently another infliximab biosimilar, Renflexis (Samsung Bioepis), has been approved by EMA and FDA; and the first biosimilar of the best-selling biological Humira (adalimumab) was approved in the US (Amjevita, Amgen) [4, 5]. These new players in the market will probably further contribute to reducing the cost of therapy. As more biosimilars of the same originator will become available, it is important that worldwide accurate registries and pharmocovigilance studies are performed, with long-term follow-up to inform clinical decision-making and close the gaps in the current knowledge about biosimilars.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Abstracted by Vito Annese, MD, Consultant Gastroenterologist, University Hospital Careggi Florence, Italy; Valiant Clinic, Dubai, UAE.

Related article
Biosimilars in the treatment of inflammatory bowel disease

1. GaBI Online - Generics and Biosimilars Initiative. Health Canada approves Inflectra biosimilar for extra indications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Biosimilars/News/Health-Canada-approves-Inflectra-biosimilar-for-extra-indications
2. Deiana S, Gabbani T, Annese V. Biosimilars in inflammatory bowel disease: a review of post-marketing experience. World J Gastroenterol. 2017;23(2):197–203. 
3. GaBI Online - Generics and Biosimilars Initiative. NOR-SWITCH study finds biosimilar infliximab not inferior to originator [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Biosimilars/Research/NOR-SWITCH-study-finds-biosimilar-infliximab-not-inferior-to-originator
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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