FRI0128 A Phase III Randomised, Double-Blind Clinical Study Comparing SB4, An Etanercept Biosimilar, With Etanercept Reference Product (Enbrel®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-Week Results)

Vencovský, Jiří; Sylwestrzak, Anna; Leszczyński, Piotr; Porawska, Wieslawa; Baranauskaitė, Asta; Tseluyko, Vira; Ждан, В. М.; Stasiuk, Barbara; Milasiene, Roma; Rodriguez, Aaron Alejandro Barrera; Cheong, Soo Yeon; Ghil, Jeehoon; Emery, Paul

doi:10.1136/annrheumdis-2015-eular.1220

Cited by 13 publications

(25 citation statements)

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“…S2). The modified Downs and Black instrument was used to assess the quality of the 22 identified abstracts for original studies [39, 63–83], with scores of fair quality (3–4) for four studies [39, 66, 70, 76], good quality (5–8) for seven studies [63, 65, 67, 68, 73, 77, 79], and excellent quality (9–12) for 11 studies [64, 69, 71, 72, 74, 75, 78, 80–83] (ESM Fig. S3).…”

Section: Resultsmentioning

confidence: 99%

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

et al. 2016

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BackgroundDespite regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and the data that underpin it.ObjectivesThe objectives of the study were to systematically collate published data for monoclonal antibodies and fusion protein biosimilars indicated for cancer, chronic inflammatory diseases, and other indications, and to explore differences in the type and weight (quantity and quality) of available evidence.MethodsMEDLINE, Embase, and ISI Web of Science were searched to September 2015. Conference proceedings (n = 17) were searched 2012 to July 2015. Included studies were categorized by originator, study type, and indication. To assess data strength and validity, risk of bias assessments were undertaken.ResultsAcross therapeutic areas, 43 named (marketed or proposed) biosimilars were identified for adalimumab, abciximab, bevacizumab, etanercept, infliximab, omalizumab, ranibizumab, rituximab, and trastuzumab originators. Infliximab CT-P13, SB2, and etanercept SB4 biosimilars have the greatest amount of published evidence of similarity with their originators, based on results of clinical studies involving larger numbers of patients or healthy subjects (N = 1405, 743, and 734, respectively). Published data were also retrieved for marketed intended copies of etanercept and rituximab.ConclusionsThis unbiased synthesis of the literature exposed significant differences in the extent of published evidence between molecules at preclinical, clinical, and post-marketing stages of development, providing clinicians and payers with a consolidated view of the available data and remaining gaps.Electronic supplementary materialThe online version of this article (doi:10.1007/s40259-016-0199-9) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

et al. 2016

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“…It is suggested that this finding could possibly be due to differences in the formulation; in contrast to etanercept, SB4 does not contain L-arginine and the needle shield does not contain natural latex. Although the finding was supported by the 52 week data,31 the European Medicines Agency concluded that it likely occurred by chance 28…”

Section: Considering Patient Managementmentioning

confidence: 92%

Biosimilars: considerations for clinical practice

et al. 2017

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With the projected expansion of the biosimilars market, there will be an increased propensity for the substitution of reference biological products with cheaper biosimilars for economic reasons (ie, non-medical switching). This will lower the cost per patient and should provide the benefit of wider access to biological therapies. However, it is essential that patients and clinicians fully understand the rationale for non-medical switching and its potential implications in terms of efficacy, safety, and immunogenicity. To date, clinical experience supports the use of biosimilars and a growing body of evidence from clinical trials and real world observational studies specifically supports clinical decision making around non-medical switching. Equally, as non-medical switching becomes more common, it is essential that pharmacovigilance systems adapt to handle the increasing volumes of data needed to effectively monitor the use of biosimilars and detect new signals. This will require a reduced reliance on registries, as well as streamlining and integration of existing systems to allow a frequent cycle of online reporting of adverse events by healthcare professionals, analysis by national authorities, and feedback to treating clinicians. This article considers the current use and future uptake of biosimilars from a clinical perspective.

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“…Serious infections were reported in 0.3% and 1.7%, respectively, and malignancies in 1.3% and 0.3% 9. One interesting difference was in injection site reactions, which were reported in 3.7% of patients taking SB4% and 17.5% of those taking Enbrel.…”

Section: Considering Clinical Data For Approved Biosimilarsmentioning

confidence: 97%

“…This was a typical example of a biosimilar study, with a 52 week randomised double blind period followed by an open label extension period up to week 100 in which all patients received SB4 and methotrexate allowing evaluation of a single switch from a bio-originator to the biosimilar 9. The double blind period included 596 patients, but the extension period was carried out only in Poland and the Czech Republic and included 245 patients 10.…”

Section: Considering Clinical Data For Approved Biosimilarsmentioning

confidence: 99%

“…The ACR20, 50, and 70 response curves up to week 52 were almost superimposable for the two products (figure 2). 9 Radiographic damage, not an absolute requirement of biosimilar studies, was also assessed; the proportion of patients with change in modified Total Sharp Score (mTSS) at week 52 greater than the smallest detectable change (2.3) was lower with SB4 than Enbrel (8.4% v 14.0%; p=0.050) 9. However, this was mainly driven by joint space narrowing and is still considered to demonstrate equivalence.…”

Section: Considering Clinical Data For Approved Biosimilarsmentioning

confidence: 99%

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Biosimilars already approved and in development

et al. 2017

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As of mid-2017, 10 tumour necrosis factor inhibitors (four for etanercept and three each for adalimumab and infliximab) and a first rituximab biosimilar are on the market, and a considerable number more are in various stages of development. The clinical trials of biosimilars, which have included long term extensions, have used various designs to look at switching between originator and biosimilar products, with reassuring results for clinical practice. For the infliximab biosimilar CT-P13 in particular, several studies have examined non-medical switching in real world practice. The results suggest that switching does not compromise safety, efficacy, or immunogenicity. However, additional data from clinical and real world switching studies, especially of switching between two or more biosimilars, are needed, as is continuing pharmacovigilance with larger databases to fill remaining gaps in the evidence. As biosimilar development continues, innovations in formulation and drug delivery technology may become of increasing interest.

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FRI0128 A Phase III Randomised, Double-Blind Clinical Study Comparing SB4, An Etanercept Biosimilar, With Etanercept Reference Product (Enbrel®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-Week Results)

Cited by 13 publications

References 0 publications

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

Biosimilars: considerations for clinical practice

Biosimilars already approved and in development

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