ReviewNature reviews. Drug discovery2012
Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars.
Review in Nature reviews. Drug discovery, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 172 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
172 citing papers in PubMed, 521 citations in OpenAlex.
- Comparison of Safety and Biological Efficacy of Anakinra (Kineret) Dispensed in Polycarbonate Plastic versus Borosilicate Glass Syringes: A Patient-Level Analysis of VCUART2 and VCUART3 Clinical Trials.The Journal of pharmacology and experimental therapeutics · 2023Trial
- Proportionate evidence in biosimilar development: when a comparative efficacy study can still change the regulatory conclusion.npj drug discovery · 2026Review
- Development of a thiol-ene microfluidic chip for CE-MS of peptides and proteins.Analytical and bioanalytical chemistry · 2026Article
- Methyl Proton Spin Relaxation (Analytical chemistry · 2026Article
- Development and Validation of SEC-UV/HRMS Procedure for Simultaneous Determination of BSA and Its Association Products.Molecules (Basel, Switzerland) · 2026Article
- Unlabeled NMR Approach with Site-Specific Methyl Assignments for Structural Evaluation of the IgG1 Fc Region.Journal of the American Chemical Society · 2026Article
- Heptad insertion extends theBiodesign research · 2026Article
- Biopharmaceutical analysis - current analytical challenges, limitations, and perspectives.Analytical and bioanalytical chemistry · 2026Review
- A Bead-Based Screening Platform for Identifying Monoclonal Antibodies That Disrupt PD-1/PD-L1 Interactions.Journal of immunology research · 2026Article
- Non-signaling protein therapeutics: a mechanism-based regulatory framework to modernize biosimilar development and global harmonization.Frontiers in medicine · 2026Review
- Analytical similarity as the primary determinant of monoclonal antibody development: toward evidence-efficient regulatory frameworks.Frontiers in drug delivery · 2026Review
- Comparative Analysis of Glycan Composition in Therapeutic Antibodies via Glycan Profiling and Intact Mass Analysis.Molecules (Basel, Switzerland) · 2025Article
- Multimodal mass spectrometric characterization of structural microheterogeneity in rituximab reference and biosimilars.International journal of biological macromolecules · 2025Article
- Sustained-Release Intra-Articular Drug Delivery: PLGA Systems in Clinical Context and Evolving Strategies.Pharmaceutics · 2025Review
- Accelerating Characterization of Therapeutic Antibodies: A Comparative Assessment of icIEF-UV/MS and the Traditional Fractionation Workflow.Journal of the American Society for Mass Spectrometry · 2025Article
- Mass Spectrometry-Driven Epitope Mapping: Application of Diethylpyrocarbonate Covalent Labeling for the Immunotherapeutic Target Programmed Cell Death Protein 1.Journal of the American Society for Mass Spectrometry · 2025Article
- Scientific Justification and Policy Recommendations to the US Food and Drug Administration for Waiving Comparative Efficacy Studies.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Hydrogen/Deuterium Exchange and Protein Oxidative Footprinting with Mass Spectrometry Collectively Discriminate the Binding of Small-Molecule Therapeutics to Bcl-2.Analytical chemistry · 2025Article
- Enzymatic Desialylation Enables Reliable Charge Variant Characterization of Highly Glycosylated and Sialylated Fc Fusion Proteins.ACS pharmacology & translational science · 2025Article
- Exploring the Correlation between LC-MS Multi-Attribute Method and Conventional Chromatographic Product Quality Assays through Multivariate Data Analysis.The AAPS journal · 2024Article
112 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
Abstract
Biologics such as monoclonal antibodies are much more complex than small-molecule drugs, which raises challenging questions for the development and regulatory evaluation of follow-on versions of such biopharmaceutical products (also known as biosimilars) and their clinical use once patent protection for the pioneering biologic has expired. With the recent introduction of regulatory pathways for follow-on versions of complex biologics, the role of analytical technologies in comparing biosimilars with the corresponding reference product is attracting substantial interest in establishing the development requirements for biosimilars. Here, we discuss the current state of the art in analytical technologies to assess three characteristics of protein biopharmaceuticals that regulatory authorities have identified as being important in development strategies for biosimilars: post-translational modifications, three-dimensional structures and protein aggregation.
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What OpenQuestion holds
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.