The evidence and issues associated with switching from originator biological disease-modifying antirheumatic drugs (DMARDs) to biosimilars are discussed by authors from French universities and hospitals [1].
Switches in clinical trials
Clinical trials have also shown Remicade and infliximab biosimilar CT‑P13 to have a comparable efficacy and safety profiles, [2] and a single switch from Remicade to CT‑P13 has been found to be a valid therapeutic option [3, 4]. A phase III transition study of patients with rheumatoid arthritis who switched from reference infliximab to SB2 found similar efficacy and safety and no difference in the rates of newly developed anti-drug antibodies between the different arms [5].
Results of a phase III randomized trial comparing biosimilar etanercept SB4 to Enbrel suggest that SB4 is less immunogenic than the originator product [6]. In a 48-week extension phase, 126 patients were maintained on SB4 and 119 were switched from Enbrel to SB4. Efficacy, changes in disease activity score 28 Joints (DAS28), clinical disease activity index (CDAI) and simplified disease activity index (SDAI), as well as radiographical progression, were similar between the two groups [7].
In a phase III study of adalimumab biosimilar SB5, at Week 24, 254 patients from SB5 continued to receive SB5, 125 patients from Humira were transitioned to SB5 and 129 patients from Humira continued to receive Humira. The efficacy, safety and immunogenicity profiles remained comparable between the three groups, with clinical response as evaluated by the ACR20 response being sustained. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by switching [8].
Switches in routine practice
The landmark NOR‑SWITCH randomized controlled trial also showed that a single switch from Remicade to CT‑P13 is not inferior to continued treatment with the infliximab originator, in terms of disease worsening [9].
The authors concluded that ‘future studies are required to confirm the preliminary … results on the safety and efficacy of switching from originator TNF inhibitors to their biosimilars’. They added that ‘information on biosimilar DMARDs given to the patients must be clear and transparent and must include the reasons for a non-medical switch, such as financial savings’.
Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest.
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References
1. Toussirot E, Marotte H. Switching from originator biological agents to biosimilars: what is the evidence and what are the issues? RMD Open. 2017:12;3(2):e000492.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab safe and effective in IBD [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-infliximab-safe-and-effective-in-IBD
3. GaBI Online - Generics and Biosimilars Initiative. Switching from reference infliximab to CT P13 in IBD patients [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from: www.gabionline.net/Biosimilars/Research/Switching-from-reference-infliximab-to-CT-P13-in-IBD-patients
4. GaBI Online - Generics and Biosimilars Initiative. Switching to biosimilar infliximab in IBD patients [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from: www.gabionline.net/Biosimilars/Research/Switching-to-biosimilar-infliximab-in-IBD-patients
5. GaBI Online - Generics and Biosimilars Initiative. Candidate infliximab biosimilar SB2 equivalent to Remicade [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from: www.gabionline.net/Biosimilars/Research/Candidate-infliximab-biosimilar-SB2-equivalent-to-Remicade
6. GaBI Online - Generics and Biosimilars Initiative. Etanercept biosimilar SB4 less immunogenic than Enbrel [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from: www.gabionline.net/Biosimilars/Research/Etanercept-biosimilar-SB4-less-immunogenic-than-Enbrel
7. Emery P, Vencovský J, Sylwestrzak A, et al. Additional efficacy results of SB4 (Etanercept biosimilar) up to Week 100: comparison between continuing SB4 and switching from reference etanercept (Enbrel) to SB4. Abstract Number: 603. Arthritis Rheumatol. 2016;68.
8. GaBI Online - Generics and Biosimilars Initiative. Positive clinical data for three anti-TNF-α biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from: www.gabionline.net/Biosimilars/Research/Positive-clinical-data-for-three-anti-TNF-a-biosimilars
9. 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 2018 Nov 2]. Available from: www.gabionline.net/Biosimilars/Research/NOR-SWITCH-study-finds-biosimilar-infliximab-not-inferior-to-originator
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