ArticlemAbs2018
Assessment of structural and functional similarity of biosimilar products: Rituximab as a case study.
Article in mAbs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed.
- Statistical Tools for Biosimilarity Assessment: A Perspective Based on WHO-recommended Approaches.The AAPS journal · 2026Article
- Rapid Identification of Counterfeit Biopharmaceuticals using Portable Fourier Transform Infrared Spectroscopy.AAPS PharmSciTech · 2026Article
- Comprehensive Physico-Chemical and Functional Similarity Assessment of Intravenous and Subcutaneous RGB-19 Drug Products as Proposed Biosimilars to Tocilizumab Reference Product.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Evaluation of Methods Employed in Establishing Preclinical Similarity of Adalimumab Biosimilars.Advances in pharmacological and pharmaceutical sciences · 2025Review
- Identification of fibrinogen as a plasma protein binding partner for lecanemab biosimilar IgG.Annals of clinical and translational neurology · 2024Article
- Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.Journal of pharmaceutical analysis · 2024Review
- Impact of Excipient Extraction and Buffer Exchange on Recombinant Monoclonal Antibody Stability.Molecular pharmaceutics · 2024Article
- Mobile Affinity Selection Chromatography Analysis of Therapeutic Monoclonal Antibodies.Analytical chemistry · 2023Article
- The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Article
- Assessing the Structural and Functional Similarity of Insulin Glargine Biosimilars.Journal of diabetes science and technology · 2023Article
- Strategies to control therapeutic antibody glycosylation during bioprocessing: Synthesis and separation.Biotechnology and bioengineering · 2022Review
- Post-translational modifications and glycoprofiling of palivizumab by UHPLC-RPLC/HILIC and mass spectrometry.Journal of proteins and proteomics · 2022Article
- Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms.Frontiers in bioengineering and biotechnology · 2022Review
- Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review.The AAPS journal · 2021Review
- Mechanisms of Therapeutic Antitumor Monoclonal Antibodies.Cancer research · 2021Review
- Simultaneous Monitoring of Monoclonal Antibody Variants by Strong Cation-Exchange Chromatography Hyphenated to Mass Spectrometry to Assess Quality Attributes of Rituximab-Based Biotherapeutics.International journal of molecular sciences · 2021Article
- On the Use of Surface Plasmon Resonance Biosensing to Understand IgG-FcγR Interactions.International journal of molecular sciences · 2021Review
- Rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in diffuse large B-cell lymphoma.Therapeutic advances in hematology · 2021Review
- ATR-FTIR spectroscopy and spectroscopic imaging for the analysis of biopharmaceuticals.Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy · 2020Review
- In-Solution IgG Titer Determination in Fermentation Broth Using Affibodies and Flow-Induced Dispersion Analysis.ACS omega · 2020Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biosimilars are products that are similar in terms of quality, safety, and efficacy to an already licensed reference/ innovator product and are expected to offer improved affordability. The most significant source of reduction in the cost of development of a biosimilar is the reduced clinical examination that it is expected to undergo as compared to the innovator product. However, this clinical relief is predicated on the assumption that there is analytical similarity between the biosimilar and the innovator product. As a result, establishing analytical similarity is arguably the most important step towards successful development of a biosimilar. Here, we present results from an analytical similarity exercise that was performed with five biosimilars of rituximab (Ristova®, Roche), a chimeric mouse/ human monoclonal antibody biotherapeutic, that are available on the Indian market. The results show that, while the biosimilars exhibited similarity with respect to protein structure and function, there were significant differences with respect to size heterogeneity, charge heterogeneity and glycosylation pattern.
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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.