ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2021
Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 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
12 citing papers in PubMed.
- Why Product Drift Is Not an Issue for Biosimilars/Biologics: Start the Same, Stay the Same.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Review of Quality Attributes and Analytical Methods Used for Comparative Analytical Assessment of Monoclonal Antibodies as Part of Successful Biosimilar Approvals in the United States and European Union.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- A Three-Arm, Tiered Comparability Strategy Bridging Post-Approval Process Changes for an Omalizumab Biosimilar (CMAB007).Pharmaceuticals (Basel, Switzerland) · 2026Article
- Best Practices for Performing Analytical and Functional Biosimilarity Assessment of Recombinant Monoclonal Antibody Biosimilars.The AAPS journal · 2026Article
- Scientific and Regulatory Standards for Dissolution Similarity: a Statistical Game of Matchmaking Neither Force to Pass or Nor Fail to Pass.AAPS PharmSciTech · 2026Review
- Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications.AAPS PharmSciTech · 2025Review
- Examining the Impact of the World Health Organization 2022 Guidelines on Evaluation of Biosimilars for Non-Local Comparators in Biosimilar Studies on Middle East and North Africa Member States.Pharmacy (Basel, Switzerland) · 2024Review
- Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer's Perspective.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Article
- The Role of PD Biomarkers in Biosimilar Development - To Get the Right Answer One Must First Ask the Right Question.Clinical pharmacology and therapeutics · 2023Review
- Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Article
- Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The principles of comparability assessments have been accepted globally as offering sensitive and reliable tools with which to evaluate potential changes to biologics that may arise either through processing changes or through the creation of a copy (biosimilar) by a different sponsor. The comparability approach has evolved through systematic advances in four areas: clear and convergent guidelines for evaluation of potential changes to biologics; risk-based systems of weighting analytical data; progressive improvements in analytical methods; and advanced understanding of post-translational modifications. Routine regulatory expectations for clinical equivalence data are being reevaluated, as they seldom contribute to the assessment of similarity. Similarly, we show that requirements to compare biosimilars and locally sourced versions of their reference products are of questionable scientific value and represent a double standard by comparison with the invariable acceptance of the clinical profiles of novel biologics without reference to their sources. The consistent application of evidentiary standards for comparability to all biologics offers an opportunity for regulators to curtail their own assessments of new biosimilars and instead to recognize comparability assessments made in another jurisdiction (reliance), thereby gaining important efficiencies in the regulatory review of biosimilars and improving the competitiveness of the biosimilars market. Such consistency can also enhance the confidence of all stakeholders, especially patients and their providers, in all biologics.
Indexed as
Identifiers
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.