Review of Biosimilar Trials and Data on Etanercept in Rheumatoid Arthritis

Chadwick, Laura; Zhao, Sizheng Steven; Mysler, Eduardo; Moots, Robert J.

doi:10.1007/s11926-018-0799-0

Cited by 31 publications

(22 citation statements)

References 48 publications

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“…Clinical trials have demonstrated Benepali to have comparable efficacy, immunogenicity and safety profile to that of Enbrel [177]. The clinical trials have shown equivalent efficacy in terms of ACR 20 response and the safety profile [177]. ACR 20 response of 78.1% in the Benapali arm has been achieved as compared to 80.3% in the Enbrel arm at week 24.…”

Section: Etanercept Biosimilarsmentioning

confidence: 99%

“…It has been approved by the EU in 16th January 2016 as a biosimilar for Enbrel (etanercept) against the indications of RA, psoriatic arthritis, plaque psoriasis and axial spondyloarthritis. Clinical trials have demonstrated Benepali to have comparable efficacy, immunogenicity and safety profile to that of Enbrel [177]. The clinical trials have shown equivalent efficacy in terms of ACR 20 response and the safety profile [177].…”

Section: Etanercept Biosimilarsmentioning

confidence: 99%

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Challenges for biosimilars: focus on rheumatoid arthritis

Akram

Pery

Butler

et al. 2020

Critical Reviews in Biotechnology

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Healthcare systems worldwide are struggling to find ways to fund the cost of innovative treatments such as gene therapies, regenerative medicine, and monoclonal antibodies (mAbs). As the world's best known mAbs are close to facing patent expirations, the biosimilars market is poised to grow with the hope of bringing prices down for cancer treatment and autoimmune disorders, however, this has yet to be realized. The development costs of biosimilars are significantly higher than their generic equivalents due to therapeutic equivalence trials and higher manufacturing costs. It is imperative that academics and relevant companies understand the costs and stages associated with biologics processing. This article brings these costs to the forefront with a focus on biosimilars being developed for Rheumatoid Arthritis (RA). mAbs have remarkably changed the treatment landscape, establishing their superior efficacy over traditional small chemicals. Five blockbuster TNFa mAbs, considered as first line biologics against RA, are either at the end of their patent life or have already expired and manufacturers are seeking to capture a significant portion of that market. Although in principle, market-share should be available, withstanding that the challenges regarding the compliance and regulations are being resolved, particularly with regards to variation in the glycosylation patterns and challenges associated with manufacturing. Glycan variants can significantly affect the quality attributes requiring characterization throughout production. Successful penetration of biologics can drive down prices and this will be a welcome change for patients and the healthcare providers. Herein we review the biologic TNFa inhibitors, which are on the market, in development, and the challenges being faced by biosimilar manufacturers.

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Section: Etanercept Biosimilarsmentioning

confidence: 99%

Section: Etanercept Biosimilarsmentioning

confidence: 99%

Challenges for biosimilars: focus on rheumatoid arthritis

Akram

Pery

Butler

et al. 2020

Critical Reviews in Biotechnology

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“…Etanercept is a recombinant, fully human, soluble, TNF-α fusion protein consisting of two copies of the extracellular ligand-binding domain of the human 75-kDa TNF-α receptor linked to the Fc portion of human immunoglobulin G1 [3]. The structure of etanercept makes it 50-to 100-fold more potent at binding to TNF-α than the endogenous unconjugated soluble TNF-α receptor [4].…”

Section: Subjectsmentioning

confidence: 99%

“…High treatment costs restrict access to high-quality biological medicines. In the case of etanercept, biosimilar versions of this recombinant protein have been developed to provide high-quality alternatives that are more economically attractive than their present recombinant TNF-α fusion protein counterparts [ 4 ]. A biosimilar is a biological agent that is highly similar but not identical to a reference product (RP) and is considered for separate marketing approval after the expiration of the RP’s patent [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

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An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects

Shennak¹,

Al-Jaouni²,

Kshirasagar

et al. 2020

Eur J Drug Metab Pharmacokinet

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Background and Objectives YLB113 is being developed as a biosimilar of the antitumor necrosis factor-alpha antagonist etanercept, which is approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) and other chronic immunemediated inflammatory diseases. An open-label, crossover, pharmacokinetic study was conducted to compare the relative bioavailability and safety of YLB113 and the etanercept reference product (RP) Enbrel ®. Methods Healthy male subjects aged 18-50 years were randomized to receive a single subcutaneous dose of YLB113 in one period and the etanercept RP in another period. A washout period of 28 days separated the two treatment periods. Blood samples were collected for pharmacokinetic analysis predose and until 480 h postdose during both periods. Results Overall, 52 subjects were enrolled, including 51 subjects who completed the first period and 43 subjects who completed the second period. The 90% confidence intervals for the least squares means derived from an analysis of the logtransformed pharmacokinetic parameters maximum serum concentration (C max), area under the serum concentration-time curve (AUC) from 0 to the last measurable concentration (AUC (0-t)) and AUC from 0 to infinity (AUC (0-∞)) for etanercept were between the limits of 80 and 125%. Thus, YLB113 met the bioequivalence criterion. YLB113 and the etanercept RP were well tolerated, with 24 subjects reporting 53 adverse events, including 42 mild and 11 moderate events. Treatmentemergent adverse events were reported by 14 and 16 subjects following the administration of YLB113 and the etanercept RP, respectively. Conclusions A single dose of YLB113 exhibited pharmacokinetic and safety profiles comparable with those of the etanercept RP in healthy adult male subjects. Therefore, YLB113 and the etanercept RP can be considered bioequivalent. These findings support the continued development of YLB113 for use in patients with RA. Jordan Food & Drug Administration unique trial number 31/Clinical/2018.

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Review of cancer cell resistance mechanisms to apoptosis and actual targeted therapies

Kulbay

Paimboeuf

Ozdemir

et al. 2021

J of Cellular Biochemistry

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The apoptosis pathway is a programmed cell death mechanism that is crucial for cellular and tissue homeostasis and organ development. There are three major caspase‐dependent pathways of apoptosis that ultimately lead to DNA fragmentation. Cancerous cells are known to highly regulate the apoptotic pathway and its role in cancer hallmark acquisition has been discussed over the past decades. Numerous mutations in cancer cell types have been reported to be implicated in chemoresistance and treatment outcome. In this review, we summarize the mutations of the caspase‐dependant apoptotic pathways that are the source of cancer development and the targeted therapies currently available or in trial.

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Review of Biosimilar Trials and Data on Etanercept in Rheumatoid Arthritis

Cited by 31 publications

References 48 publications

Challenges for biosimilars: focus on rheumatoid arthritis

Challenges for biosimilars: focus on rheumatoid arthritis

An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects

Review of cancer cell resistance mechanisms to apoptosis and actual targeted therapies

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