Switching from adalimumab originator and ABP501 to SB5 in arthritis patients

Biosimilars/Research | Posted 28/10/2022 post-comment0 Post your comment

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.

X-ray1 MD001877 V13E03

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.

Editor’s Comment
Readers interested to learn more about biosimilars in Brazil are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

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 

GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here

GaBI Journal Citation Impact
2.2 – CiteScore 2021 (calculated on 5 May 2022)
2.4 – CiteScoreTracker 2022 (Last updated on 5 October 2022)

Submit a manuscript to GaBI Journal

Related articles
Adalimumab biosimilar MSB11022: PK and tolerability of autoinjector versus pre-filled syringe

Adalimumab biosimilar has comparable pharmacokinetics to Humira


The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Actualizaciones de las monografías de la Farmacopea Europea sobre productos bioterapéuticos

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.


Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Actualizaciones de las monografías de la Farmacopea Europea sobre productos bioterapéuticos

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 


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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010