South Korean electronics giant Samsung and biotechnology company Biogen Idec (Biogen) joint venture Samsung Bioepis, along with Biogen, announced on 13 June 2018 results of a pooled analysis combining data from three phase III trials that compared the efficacy and safety of anti-tumour necrosis factor (anti-TNF) biosimilars to their reference biologicals.
The analysis, which the companies say is the first of its kind, examined patients with moderate to severe rheumatoid arthritis (RA) and ‘may help scientists answer critical questions about anti-TNF treatment among specific patient populations’, according to Samsung Bioepis and Biocon.
The analysis included data from Benepali (SB4, etanercept biosimilar), Flixabi (SB2, infliximab biosimilar) and Imraldi (SB5, adalimumab biosimilar). Benepali, Flixabi and Imraldi were approved in Europe in January 2016, May 2016 and August 2017, respectively [1]. The data were pooled and analysed to assess the impact of anti-drug antibodies (ADAs) on efficacy and tolerability, as well as radiographic progression by disease activity state.
Immunogenicity data from 1,710 patients with RA pooled from the three studies revealed that the incidence of ADAs was comparable between the biosimilars and their reference products. This indicated that the biosimilars were equally effective compared to their biological counterparts, according to Biogen and Samsung Bioepis. In addition, efficacy and injection site reactions/infusion related reactions (ISR/IRR) were evaluated in relation to the presence of ADAs. Data suggested that the development of ADAs is associated with reduced clinical efficacy and increased incidence of ISR/IRR in patients with RA [2].
Radiographic data from 1,263 patients participating in the studies were collected and grouped based on patient’s disease activity state at the time of the primary endpoint assessment (Week 24 or Week 30). Radiographic progression was measured using the modified Total Sharp Score (mTSS) at Week 0 and Week 52 or Week 54. Overall, radiographic progression was minimal and comparable across all treatment groups. In addition, the pooled biosimilar group tended to have a lower mean change in mTSS compared with the pooled reference group, which slows down the progression of this disease [3].
These data were presented at the European League Against Rheumatism (EULAR) 2018 Annual Meeting, which was held on 13−16 June 2018 in Amsterdam, The Netherlands.
According to Biogen and Samsung Bioepis, since Benepali and Flixabi were approved in Europe in 2016, the two biosimilars have treated nearly 80,000 patients across 23 countries. The companies expect to launch Imraldi in Europe in October 2018. Samsung Bioepis also received US Food and Drug Administration approval for its infliximab biosimilar SB2 [Renflexis (infliximab-abda)] in April 2017 [4].
Conflict of interest
Several of the authors of the abstracts [2, 3] reported conflicts of interest, including having received grant/research support from, having acted as a consultant for, or being an employee of various pharmaceutical companies. For full details of the authors’ conflict of interest, see the abstracts [2, 3].
Editor’s Comment
It should be noted that data of the studies presented in this article were published as abstracts and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. Emery P, Weinblatt M, Smolen JS, et al. THU0184: Impact of immunogenicity on clinical efficacy and administration related reaction in TNF inhibitors: a pooled-analysis from three biosimilar studies in patients with rheumatoid arthritis. European League Against Rheumatism (EULAR) 2018 Annual Meeting; 13−16 June 2018; Amsterdam, The Netherlands.
3. Smolen JS, Weinblatt M, Emery P, et al. THU0201: A pooled analysis of three TNF-α inhibitor biosimilar studies in patients with rheumatoid arthritis comparing radiographic progression by disease activity states. European League Against Rheumatism (EULAR) 2018 Annual Meeting; 13−16 June 2018; Amsterdam, The Netherlands.
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar infliximab Renflexis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-infliximab-Renflexis
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Source: Biogen, EULAR, Samsung Bioepis
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