Researchers from Argentina, Brazil, Germany, the UK and the US investigated switching from originator biologicals to biosimilars [1].
Clinical and real-word data on the effects of switching are currently limited to transition studies of approved biosimilars. Therefore, the aim of this study was to summarize the current literature on switching.
The authors carried out a MEDLINE/Web search and identified studies where healthy volunteers or patients receiving adalimumab (ADA), etanercept (ETN), infliximab (INF) or rituximab (RTX) were switched between originator biologicals and biosimilars.
Switching data was available for 12 studies in rheumatic diseases (4: INF/CT‑P13, 1: INF/SB2, 2: INF/unidentified biosimilar, 2: ETN/SB4, 1: ETN/GP2015, 1: ADA/SB5, and 1: RTX/CT‑P10). The INF/CT‑P13 studies showed efficacy and safety of INF and CT‑P13 to be similar in switch and maintenance groups and similar pre- and post-switch. Immunogenicity was assessed in three studies and did not change post-switch. In the INF/SB2 study, switch and maintenance groups had similar safety, efficacy, and immunogenicity profiles; comparisons pre- and post-switch were not made. The other 2 INF/biosimilar switch studies showed no difference in efficacy or safety 6 months post-switch. The ETN/SB4 and ETN/GP2015 phase I studies showed similar pharmacokinetic parameters for ETN and the 2 biosimilars. In patients with rheumatoid arthritis, similar safety, efficacy, and immunogenicity profiles were seen between ETN/SB4 (switch) and SB4/SB4 (maintenance) groups. The ADA/SB5 study showed clinical measures of efficacy, safety, and immunogenicity to be similar in the switch and maintenance groups; comparisons pre- and post-switch were not made. The RTX/CT-P10 study showed clinical measures of efficacy and safety to be similar in the switch and maintenance groups. Efficacy pre- and post-switch could not be compared.
The authors concluded that ‘switching data is starting to become available; mostly with INF but also emerging for other drugs’. In addition, the authors believe that ‘while initial transition data confirm maintenance of efficacy and safety, additional data from clinical and real-world switching studies, especially of switching between biosimilars, are required, as is continuing pharmacovigilance’. They added that ‘any switching should remain a clinical decision made jointly by the treating physician and patient on an individual patient basis supported by scientific evidence’.
These data were presented at the American College of Rheumatology’s (ACR) 2016 Annual Meeting, which was held on 11-16 November 2016 in Washington DC, USA.
Conflict of interest
The authors of the abstract [1] reported conflict of interest including being an employee of Pfizer. For full details of the authors’ conflict of interest, see the abstract [1].
Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.
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Reference
1. Moots RJ, et al. Switching to biosimilars in rheumatology: evidence-based practice. American College of Rheumatology’s (ACR) 2016 Annual Meeting; 11-16 November 2016; Washington, DC, USA.
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