ArticlemAbs
Characterization and comparison of commercially available TNF receptor 2-Fc fusion protein products.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
22 citing papers in PubMed, 60 citations in OpenAlex.
- Anti-Inflammatory and Synaptic Protective Effects of TNF-α Inactivation in the MDX Mouse Model.Current issues in molecular biology · 2026Article
- Development of a trispecific fusion protein based on angiotensin-converting enzyme 2, glycoprotein 130, and tumor necrosis factor receptor 2 as a promising therapeutic for COVID-19.Molecular biomedicine · 2025Article
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- Enzymatic Desialylation Enables Reliable Charge Variant Characterization of Highly Glycosylated and Sialylated Fc Fusion Proteins.ACS pharmacology & translational science · 2025Article
- Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.Journal of pharmaceutical analysis · 2024Review
- Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms.Frontiers in bioengineering and biotechnology · 2022Review
- Similar biologics in India: A story of access or potential for compromise?The Indian journal of medical research · 2020Review
- At-line high throughput site-specific glycan profiling using targeted mass spectrometry.Biotechnology reports (Amsterdam, Netherlands) · 2020Article
- Relating glycoprotein structural heterogeneity to function - insights from native mass spectrometry.Current opinion in structural biology · 2019Review
- Complete mapping of disulfide linkages for etanercept products by multi-enzyme digestion coupled with LC-MS/MS using multi-fragmentations including CID and ETD.Journal of food and drug analysis · 2019Article
- Structural and In Vitro Functional Comparability Analysis of Altebrel™, a Proposed Etanercept Biosimilar: Focus on Primary Sequence and Glycosylation.Pharmaceuticals (Basel, Switzerland) · 2019Article
- Physicochemical characterization and phase I study of CMAB008, an infliximab biosimilar produced by a different expression system.Drug design, development and therapy · 2019Article
- High resolution fingerprinting of single and double-stranded RNA using ion-pair reverse-phase chromatography.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2019Article
- Testing the potency of anti-TNF-α and anti-IL-1β drugs using spheroid cultures of human osteoarthritic chondrocytes and donor-matched chondrogenically differentiated mesenchymal stem cells.Biotechnology progress · 2018Article
- Variability of intended copies for etanercept (Enbrel®): Data on multiple batches of seven products.mAbs · 2018Article
- Targeted, Site-specific quantitation of N- and O-glycopeptides usingGlycoconjugate journal · 2017Article
- Article
- Etanercept biosimilars.Rheumatology international · 2015Review
- Article
- Article
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Authors and funding
8 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Because of rapidly increasing market demand and rising cost pressure, the innovator of etanercept (Enbrel®) will inevitably face competition from biosimilar versions of the product. In this study, to elucidate the differences between the reference etanercept and its biosimilars, we characterized and compared the quality attributes of two commercially available, biosimilar TNF receptor 2-Fc fusion protein products. Biosimilar 1 showed high similarity to Enbrel® in critical quality attributes including peptide mapping, intact mass, charge variant, purity, glycosylation and bioactivity. In contrast, the intact mass and MS/MS analysis of biosimilar 2 revealed a mass difference indicative of a two amino acid residue variance in the heavy chain (Fc) sequences. Comprehensive glycosylation profiling confirmed that biosimilar 2 has significantly low sialylated N-oligosaccharides. Biosimilar 2 also displayed significant differences in charge attributes compared with the reference product. Interestingly, biosimilar 2 exhibited similar affinity and bioactivity levels compared with the reference product despite the obvious difference in primary structure and partial physiochemical properties. For a biosimilar development program, comparative analytical data can influence decisions about the type and amount of animal and clinical data needed to demonstrate biosimilarity. Because of the limited clinical experience with biosimilars at the time of their approval, a thorough knowledge surrounding biosimilars and a case-by-case approach are needed to ensure the appropriate use of these products.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.