Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab

Abstract

Summary Background Biosimilar versions of widely prescribed drugs, including the tumour‐necrosis factor antagonist infliximab, are becoming increasingly available. As biosimilars are not identical copies of reference products, evidence may be required to demonstrate that switching between a reference biologic and biosimilars is safe and efficacious. To establish interchangeability, US Food and Drug Administration guidance states that studies must demonstrate that biosimilars remain equivalent or non‐inferior to a reference product after multiple switches between products. Aims To investigate the evidence evaluating the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Methods Published studies presenting data on switching between reference and biosimilar infliximab were identified by searching the MEDLINE database. Congress abstracts were identified by searching the EMBASE database and manually searching abstracts from relevant congresses. Results A total of 113 journal articles and 149 abstracts were found. Of these, 70 were considered relevant and included in this analysis. Most of the publications were uncontrolled, observational studies. Data from six randomised, controlled trials were identified. In general, the evidence revealed no clinically important efficacy or safety signals associated with switching. Conclusions While available data have not identified significant risks associated with a single switch between reference and biosimilar infliximab, the studies available currently report on only single switches and were mostly observational studies lacking control arms. Additional data are needed to explore potential switching risks in various populations and scenarios.

<p>Biosimilars to Antitumor Necrosis Factor Agents in Inflammatory Bowel Disease</p>

“…40 Overall, the evidence supports the safety and efficacy of a one-time switch between the RP and the infliximab biosimilar. 30 This is in line with recommendations recently published in a consensus document by multidisciplinary experts. 41 It should be mentioned that data on the safety and efficacy of switching from one biosimilar to another of the same originator or of multiple switches among different molecules are lacking.…”

“…28,29 The US Food and Drug Administration (FDA) approval of two other infliximab biosimilars (SB2 and PF-06438179) and the approvals of NI-071 in Japan and BOW015 in India were also based on studies on rheumatoid arthritis. 30,31 CT-P13 remains the most widely studied biosimilar for IBD. 32 Is CT-P13 as Effective as the Reference Product in Patients with Inflammatory Bowel Disease?…”

Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients

“…The effectiveness and safety of biosimilars in IBD is well‐proven, but there remains a lack of knowledge about these data among patients, and this contributes to the nocebo effect . To minimise misconceptions, health‐care providers should adequately inform and educate their patients .…”

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

“…Data from the DANBIO registry of patients with inflammatory rheumatic disease demonstrated that a mandatory switch from reference infliximab to CT-P13 resulted in only minor changes to outpatient healthcare resource use [11], whereas a recent study found that the modest cost savings offered by biosimilar etanercept did not justify the additional workload involved in actively switching patients from the RP in some Swedish counties [162]. Data regarding single switches are accumulating, but, to our knowledge, no published studies have investigated cross-switching (between two biosimilars) or multiple/ repeated switches in RA or IBD [159,163,164] with regard to efficacy, safety, or cost considerations. However, evidence regarding multiple switching is emerging in psoriasis, with no impact on efficacy, safety, or immunogenicity detected after up to four switches between reference adalimumab and GP2017 [165] or up to three switches between reference etanercept and GP2015 [166].…”