A randomized phase I comparative pharmacokinetic study comparing SB5 with reference adalimumab in healthy volunteers

Shin, Dong Wan; Lee, Y.; Kim, H.; Körnicke, T.; Fuhr, Rainard

doi:10.1111/jcpt.12583

Cited by 55 publications

(52 citation statements)

References 14 publications

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“…The European Commission granted a marketing authorization for SB5 in August 2017. Pharmacokinetic (PK) equivalence and comparable safety for SB5 and ADA were demonstrated in a phase I study in healthy individuals . In a phase III randomized study in patients with moderate‐to‐severe RA, equivalent efficacy was demonstrated for SB5 and ADA, as seen in percentages of patients meeting the ACR 20% improvement criteria (achieving an ACR20 response) (72.4% and 72.2%, respectively) and additional efficacy end points up to 24 weeks; SB5 was well tolerated, with PK, safety, and immunogenicity profiles comparable to those of ADA .…”

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confidence: 88%

“…ADA is a recombinant human IgG1 specific for TNF that is approved for the treatment of RA as well as several other inflammatory conditions . SB5 (Imraldi; Samsung Bioepis) was developed as an ADA biosimilar and has an identical amino acid sequence and physicochemical and in vitro functional properties similar to those of reference ADA . The European Commission granted a marketing authorization for SB5 in August 2017.…”

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confidence: 99%

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Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis

Weinblatt

Baranauskaitė

Dokoupilová

et al. 2018

Arthritis & Rheumatology

114

129

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ObjectiveThe 24‐week equivalent efficacy and comparable safety results of the biosimilar SB5 and reference adalimumab (ADA) from the phase III randomized study in patients with moderate‐to‐severe rheumatoid arthritis (RA) have been reported previously. We undertook this transition study to evaluate patients who switched from ADA to SB5 or who continued to receive SB5 or ADA up to 52 weeks.MethodsIn this phase III study, patients were initially randomized 1:1 to receive SB5 or ADA (40 mg subcutaneously every other week). At 24 weeks, patients receiving ADA were rerandomized 1:1 to continue with ADA (ADA/ADA group) or to switch to SB5 (ADA/SB5 group) up to week 52; patients receiving SB5 continued with SB5 for 52 weeks (SB5 group). Efficacy, safety, and immunogenicity were evaluated up to 52 weeks.ResultsThe full analysis set population consisted of 542 patients (269 in the SB5 group, 273 in the ADA overall group [patients who were randomized to receive ADA at week 0], 125 in the ADA/SB5 group, and 129 in the ADA/ADA group). The percentages of patients meeting the American College of Rheumatology 20%, 50%, or 70% improvement criteria (achieving an ACR20, ACR50, or ACR70 response) at week 24 were maintained after the transition from ADA to SB5, and these response rates were comparable across treatment groups throughout the study. ACR20 response rates ranged from 73.4% to 78.8% at week 52. Radiographic progression was minimal and comparable across treatment groups. The safety profile and the incidence of antidrug antibodies were comparable across treatment groups after transition.ConclusionSB5 was well tolerated over 1 year in patients with RA, with efficacy, safety, and immunogenicity comparable to those of ADA. Switching from ADA to SB5 had no treatment‐emergent issues such as increased adverse events, increased immunogenicity, or loss of efficacy.

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confidence: 88%

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confidence: 99%

Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis

Weinblatt

Baranauskaitė

Dokoupilová

et al. 2018

Arthritis & Rheumatology

114

129

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“…To our knowledge, no published clinical trials evaluating the approved adalimumab biosimilars ABP 501, BI 695501, or SB5 in IBD, or real-world evidence for other infliximab biosimilars exist. All three adalimumab biosimilars have demonstrated pharmacokinetic similarity to the RP in equivalence studies in healthy subjects [125][126][127] and similar efficacy and safety in clinical trials in patients with RA [128][129][130].…”

Section: Gastroenterologists' Perspective: Earlier Introduction Of Bimentioning

confidence: 95%

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Kim

Alten

Avedano³

et al. 2020

Drugs

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Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars-biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators-can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.

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“…Although SB5 has slightly different non-glycosylated heavy chain (NGHC) levels compared to the reference product, the difference had no significant clinical impact. 19,20 Charge heterogeneity…”

Section: Size Heterogeneitymentioning

confidence: 99%

Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab

Lee

Yang

et al. 2018

mAbs

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Biosimilars are biologic products that are highly similar to a licensed reference product in terms of quality, safety, and efficacy. SB5 is a biosimilar of Humira® (adalimumab) developed by Samsung Bioepis. To demonstrate its biosimilarity in quality to Humira®, we performed a comprehensive characterization in terms of structure, physicochemical properties, and biological properties following the International Conference on Harmonization, US Food and Drug Administration, and European Medicines Agency guidelines. We analyzed all available batches of SB5 and more than 100 EU- and US-sourced lots of Humira® using state-of-the-art methods whenever possible, and compared the two sets of data. The structural properties comprised primary and higher-order structures and N-glycosylation. The physicochemical characteristics were categorized into liquid chromatographic patterns and electrophoretic pattern concerning size and charge heterogeneity. The biological properties were examined by in vitro functional assays.Overall, SB5 and Humira® were shown to be similar to each other in terms of quality attributes. For some of the quality attributes, minor differences were observed. However, the observed differences have been adequately addressed and demonstrated these do not translate into clinically meaningful differences in terms of safety, purity, and potency.

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A randomized phase I comparative pharmacokinetic study comparing SB5 with reference adalimumab in healthy volunteers

Cited by 55 publications

References 14 publications

Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis

Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab

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