The introduction and availability of biosimilars entails a considerable increase in the patient access as well as a decrease in the patient cost. Thus, biosimilars could be the answer to the economic impact of the reference biological.
Switching from a biological originator to a biosimilar is supported by growing evidence but data on the switch between different biosimilars of the same reference product are limited.
A study carried out by Scrivo et al. was designed to evaluate the effectiveness of the non-medical switch both between adalimumab (ADA) originator and SB5 biosimilar and between two different ADA biosimilars in patients with inflammatory chronic arthritis.
The study enrolled adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) that switched from ADA originator to SB5 or from AB501 to SB5 due to administrative/economic reasons. At baseline (T0) and after 4 months (T4) Scrivo et al. assessed the disease activity by composite indexes [Disease Activity Score-28 (DAS28)-CRP for RA, PsA Disease Activity in Psoriatic Arthritis (DAPSA) for PsA, Ankylosing Spondylitis (AS) Disease Activity Score (ASDAS-CRP) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; 0-10) for axSpA] and patient-reported outcomes (PROs) [patient global assessment (PGA), pain visual analogue scale (VAS), Health Assessment Questionnaire (HAQ)].
The results showed that 110 patients [33 RA, 40 PsA, 37 axSpA; F:M = 49:61; median age 56 years (25th‒75th percentile 48‒66)] switched from ADA originator to SB5. At T0, patients had been treated with Humira for a median of 48 (32‒72) months; 102/110 (92.7%) patients were in remission-low disease activity. At T4, we observed a significant reduction of patients in remission/low disease activity (T0 92.7% vs T4 80.9%; p = 0.009), with a risk of moderate-high disease activity significantly higher after the switch [RR 2.6 (95% IC 1.2 to 5.7), p = 0.01]. No differences were found in DAS28-CRP, DAPSA, ASDAS-CRP, and BASDAI, while patients with RA and PsA experienced a worsening in the PGA (p = 0.04 and p = 0.02, respectively). In PsA patients a worsening in HAQ was also observed (p = 0.03).
Forty patients switched from ABP501 biosimilar to SB5 [12 with RA, 25 with PsA, and 3 with axSpA; F:M = 24:16; median age 56 years (25th‒75th percentile 44‒66)]. At T0, patients had been treated with ABP501 for a median of 11 (7‒18) months; 21/40 (52.5%) patients were in remission-low disease activity. At T4, no differences in DAS28-CRP and DAPSA nor in the percentage of patients in remission/low disease activity were found compared to baseline. Likewise, there were no differences in PROs.
The results also provided a reassuring profile of effectiveness when switching from ADA originator to one of its biosimilars and between two different biosimilars. Nevertheless, the worse outcome in PROs in patients initially treated with the bio-originator could be due to a possible nocebo response, which should encourage comprehensive communication with patients.
Adalimumab is sold under the brand name Humira, among others, is a popular antibody treatment for a number of inflammatory conditions.
ABP501 (Amgevita) marketed by Amgen was the first European Commission approved adalimumab biosimilar. Comparative analysis has shown that Amgevita has similar physicochemical properties and biological activity to the reference product. SB5 (Imraldi) marketed by Biogen, demonstrated equivalent pharmacokinetics in a study in healthy subjects [2].
Conflict of interest
The authors of the research paper [1] did not provide the conflict of interest statement.
Abstracted by Silvia Mancuso, Dipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari, Sapienza Università di Roma, Italy.
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Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods
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References
1. Scrivo R, Castellani C, Mancuso S, et al. Effectiveness of non-medical switch from adalimumab bio-originator to SB5 biosimilar and from ABP501 adalimumab biosimilar to SB5 biosimilar in patients with chronic inflammatory arthropathies: a monocentric observational study. Clin Exp Rheumatol. 2022 Jul 28. doi:10.55563/clinexprheumatol/bf00j9. Online ahead of print.
2. GaBI Online - Generics and Biosimilars Initiative. Adalimumab biosimilars in Europe: a review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 28]. Available from: www.gabionline.net/biosimilars/general/Adalimumab-biosimilars-in-Europe-a-review
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