ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2016
Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 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
41 citing papers in PubMed.
- Pharmacokinetic, Safety, and Immunogenicity Similarity of High- and Low-Concentration Formulations of Adalimumab Biosimilar ABP 501, Adalimumab-Atto.Pharmacology research & perspectives · 2026Trial
- An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis.Arthritis research & therapy · 2019Trial
- Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.Annals of the rheumatic diseases · 2017Trial
- A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab.Annals of the rheumatic diseases · 2017Trial
- Analytical Ultracentrifugation for Biopharmaceutical Characterization and Quality Control.International journal of molecular sciences · 2026Review
- Host cell protein impurities in therapeutic proteins: overview of advances in detection, nonconventional removal technologies and immunogenicity assessment.Journal of biological engineering · 2026Review
- Engineering Extended Release Profiles for Biologic Formulations via Chemical Cross-Linking of Poloxamer 407 Hydrogels.ACS omega · 2025Article
- Article
- Assessing the Comparability of Degradation Profiles Between Biosimilar and Originator Anti-VEGF Monoclonal Antibodies Under Thermal Stress.Pharmaceuticals (Basel, Switzerland) · 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
- "Small is beautiful" - Examining reliable determination of low-abundant therapeutic antibody glycovariants.Journal of pharmaceutical analysis · 2024Article
- Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.Journal of pharmaceutical analysis · 2024Review
- Demonstrating analytical similarity of a biosimilar HLX04 to bevacizumab with a panel of state-of-the-art methods and tiering of quality attributes.Analytical and bioanalytical chemistry · 2023Article
- Article
- Characterization of FcγRIa (CD64) as a Ligand Molecule for Site-Specific IgG1 Capture: A Side-By-Side Comparison with Protein A.Langmuir : the ACS journal of surfaces and colloids · 2022Article
- Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Review
- Adalimumab and ABP 501 in the Treatment of a Large Cohort of Patients with Inflammatory Arthritis: A Real Life Retrospective Analysis.Journal of personalized medicine · 2022Article
- Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms.Frontiers in bioengineering and biotechnology · 2022Review
- A novel twin-column continuous chromatography approach for separation and enrichment of monoclonal antibody charge variants.Engineering in life sciences · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundABP 501 is being developed as a biosimilar to adalimumab. Comprehensive comparative analytical characterization studies have been conducted and completed.
objectiveThe objective of this study was to assess analytical similarity between ABP 501 and two adalimumab reference products (RPs), licensed by the United States Food and Drug Administration (adalimumab [US]) and authorized by the European Union (adalimumab [EU]), using state-of-the-art analytical methods.
methodsComprehensive analytical characterization incorporating orthogonal analytical techniques was used to compare products. Physicochemical property comparisons comprised the primary structure related to amino acid sequence and post-translational modifications including glycans; higher-order structure; primary biological properties mediated by target and receptor binding; product-related substances and impurities; host-cell impurities; general properties of the finished drug product, including strength and formulation; subvisible and submicron particles and aggregates; and forced thermal degradation.
resultsABP 501 had the same amino acid sequence and similar post-translational modification profiles compared with adalimumab RPs. Primary structure, higher-order structure, and biological activities were similar for the three products. Product-related size and charge variants and aggregate and particle levels were also similar. ABP 501 had very low residual host-cell protein and DNA. The finished ABP 501 drug product has the same strength with regard to protein concentration and fill volume as adalimumab RPs. ABP 501 and the RPs had a similar stability profile both in normal storage and thermal stress conditions.
conclusionBased on the comprehensive analytical similarity assessment, ABP 501 was found to be similar to adalimumab with respect to physicochemical and biological properties.
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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.