New data on infliximab and adalimumab biosimilars at EULAR 2022

Biosimilars/News | Posted 15/07/2022 post-comment0 Post your comment

The Annual European Congress of Rheumatology (EULAR 2022) was held at the beginning of June 2022. This platform was used to announce the results of a study that showed that, in patients with rheumatoid arthritis, statistically greater improvements in clinical outcomes with subcutaneous infliximab, compared to intravenous infliximab. In addition, Samsung Bioepis announced new data on their established adalimumab biosimilar Imraldi (Hadlima outside Europe).

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Subcutaneous infliximab
EULAR 2022 was the platform for researchers to announce the results of a new post-hoc analysis of a pivotal phase III randomized controlled clinical trial related to subcutaneous or intravenous infliximab in rheumatoid arthritis patients. This showed that when patients suffering from rheumatoid arthritis were given either subcutaneous or intravenous infliximab for 30 weeks, there was a statistically significant difference in favour of subcutaneous treatment. This related to all clinical variables, including low disease activity rates and remission rate. In addition, when patients were switched at Week 30 from intravenous to subcutaneous infliximab, the proportion of patients achieving either low disease activity rates or a ‘good response’, was increased at Week 54. This suggests improved responses after switching from intravenous to subcutaneous infliximab.

Subcutaneous infliximab is produced by Celltrion, who have already presented findings related to its use in the treatment of patients with inflammatory bowel disease (IBD) [1]. Infliximab is a monoclonal antibody that is used to treat ankylosing spondylitis, Crohn’s disease, psoriatic arthritis and psoriasis, rheumatoid arthritis, ulcerative colitis. The originator/reference blockbuster drug was developed by and is sold as Remicade [2].

Samsung Bioepis’ adalimumab biosimilar
EULAR 2022 was also the platform for Samsung Bioepis to announce new data from the phase I study of the new formulation of their adalimumab biosimilar (SB5). The randomized, single-blind, two-arm, parallel group, single-dose study in healthy subjects, demonstrated pharmacokinetic equivalence between the new SB5 formulation and the original SB5 formulation.

In addition, the company designed a pan-European real-world study, ‘PROPER’ (sponsored by Biogen GmbH), to provide insights into outcomes of the transition from reference adalimumab to adalimumab biosimilar (SB5). The results of this study showed that treatment effectiveness was maintained at 48 weeks after switching from reference adalimumab to SB5, with most patients continuing on SB5 throughout.

SB5 was first approved in Europe in 2017 [3]. Adalimumab is a monoclonal antibody indicated for the treatment of a number of inflammatory conditions including rheumatoid arthritis, psoriasis and IBD. It targets the inflammatory molecule tumour necrosis factor alpha (TNF- α), and is sold under the brand name Humira by the originator company, AbbVie [4].

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Biosimilars of adalimumab

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar advances for Celltrion Healthcare [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 15]. Available from: www.gabionline.net/biosimilars/general/Biosimilar-advances-for-Celltrion-Healthcare
2. GaBI Online - Generics and Biosimilars Initiative. EMA receives second application for biosimilar infliximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 15]. Available from: www.gabionline.net/biosimilars/news/EMA-receives-second-application-for-biosimilar-infliximab
3.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 15].  Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
4. GaBI Online - Generics and Biosimilars Initiative. New data on adalimumab biosimilars from Samsung Bioepis and Boehringer Ingelheim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 15]. Available from: www.gabionline.net/biosimilars/research/new-data-on-adalimumab-biosimilars-from-samsung-bioepis-and-boehringer-ingelheim

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