ArticleAnalytical chemistry2017
A Multidimensional Analytical Comparison of Remicade and the Biosimilar Remsima.
Article in Analytical chemistry, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 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
24 citing papers in PubMed, 69 citations in OpenAlex.
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- Systematic Fe(II)-EDTA Method of Dose-Dependent Hydroxyl Radical Generation for Protein Oxidative Footprinting.Analytical chemistry · 2023Article
- Physicochemical characterization and functionality comparison of Humira®(adalimumab), Remicade®(infliximab) and Simponi Aria®(golimumab).International journal of pharmaceutics · 2023Article
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- Modeling study of long-term stability of the monoclonal antibody infliximab and biosimilars using liquid-chromatography-tandem mass spectrometry and size-exclusion chromatography-multi-angle light scattering.Analytical and bioanalytical chemistry · 2023Article
- Mass Spectrometry Methods for Measuring Protein Stability.Chemical reviews · 2022Review
- Advanced assessment through intact glycopeptide analysis of Infliximab's biologics and biosimilar.Frontiers in molecular biosciences · 2022Article
- Streamlining the Characterization of Disulfide Bond Shuffling and Protein Degradation in IgG1 Biopharmaceuticals Under Native and Stressed Conditions.Frontiers in bioengineering and biotechnology · 2022Article
- Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review.The AAPS journal · 2021Review
- Rapid structural discrimination of IgG antibodies by multicharge-state collision-induced unfolding.RSC advances · 2021Article
- QuantitativePharmaceutics · 2021Article
- Overview of Humira® Biosimilars: Current European Landscape and Future Implications.Journal of pharmaceutical sciences · 2021Review
- Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product.Pharmaceutical research · 2020Article
- Relating glycoprotein structural heterogeneity to function - insights from native mass spectrometry.Current opinion in structural biology · 2019Review
- VHH characterization. Comparison of recombinant with chemically synthesized anti-HER2 VHH.Protein science : a publication of the Protein Society · 2019Article
- Forced Degradation Testing as Complementary Tool for Biosimilarity Assessment.Bioengineering (Basel, Switzerland) · 2019Article
- Quantitative collision-induced unfolding differentiates model antibody-drug conjugates.Protein science : a publication of the Protein Society · 2019Article
- Evolution of Structural Biology through the Lens of Mass Spectrometry.Analytical chemistry · 2019Review
- Signature of Antibody Domain Exchange by Native Mass Spectrometry and Collision-Induced Unfolding.Analytical chemistry · 2018Article
- Development of an LC-MS/MS peptide mapping protocol for the NISTmAb.Analytical and bioanalytical chemistry · 2018Article
Corrections and comments
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Authors and funding
15 authors at 4 institutions in 1 country.
Funding
Abstract
In April 2016, the Food and Drug Administration approved the first biosimilar monoclonal antibody (mAb), Inflectra/Remsima (Celltrion), based off the original product Remicade (infliximab, Janssen). Biosimilars promise significant cost savings for patients, but the unavoidable differences between innovator and copycat biologics raise questions regarding product interchangeability. In this study, Remicade and Remsima were examined by native mass spectrometry, ion mobility, and quantitative peptide mapping. The levels of oxidation, deamidation, and mutation of individual amino acids were remarkably similar. We found different levels of C-terminal truncation, soluble protein aggregates, and glycation that all likely have a limited clinical impact. Importantly, we identified more than 25 glycoforms for each product and observed glycoform population differences, with afucosylated glycans accounting for 19.7% of Remicade and 13.2% of Remsima glycoforms, which translated into a 2-fold reduction in the level of FcγIIIa receptor binding for Remsima. While this difference was acknowledged in Remsima regulatory filings, our glycoform analysis and receptor binding results appear to be somewhat different from the published values, likely because of methodological differences between laboratories and improved glycoform identification by our laboratory using a peptide map-based method. Our mass spectrometry-based analysis provides rapid and robust analytical information vital for biosimilar development. We have demonstrated the utility of our multiple-attribute monitoring workflow using the model mAbs Remicade and Remsima and have provided a template for analysis of future mAb biosimilars.
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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.