ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2019
An Efficient Development Paradigm for Biosimilars.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed.
- Analytical similarity as the primary determinant of monoclonal antibody development: toward evidence-efficient regulatory frameworks.Frontiers in drug delivery · 2026Review
- Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Review
- 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
- Practical Strategies for Advanced Practitioners Streamlining the Integration of Oncology Biosimilar Therapies Into Practice.Journal of the advanced practitioner in oncology · 2022Review
- Challenges Faced by the Biopharmaceutical Industry in the Development and Marketing Authorization of Biosimilar Medicines in BRICS-TM Countries: An Exploratory Study.Pharmaceutical medicine · 2021Article
- Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Article
- Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Article
- Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars.Pharmaceuticals (Basel, Switzerland) · 2021Article
- The Path Towards a Tailored Clinical Biosimilar Development.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Review
- Understanding the Role of Comparative Clinical Studies in the Development of Oncology Biosimilars.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The current development paradigm for biosimilars required by regulators in highly regulated jurisdictions is derived from the development of novel drugs and is unnecessarily burdensome and inefficient. It requires the accumulation of data from analytical, nonclinical (including in vivo studies in some jurisdictions), and clinical studies (including powered efficacy studies in most cases); this paradigm is known as 'totality of evidence' (ToE) and does not admit a conclusion of biosimilarity from analytical data alone. The record of biosimilar approvals in these jurisdictions shows that no biosimilar candidate that has been found highly similar to its reference in analytical and pharmacokinetic studies has failed to be approved. We propose a new paradigm ('confirmation of sufficient likeness', CSL) that emphasizes the demonstration of analytical resemblance between the biosimilar candidate and its reference, and permits the conclusion of biosimilarity upon this basis. CSL does not entail bridging studies between reference products, in vivo nonclinical studies, or powered efficacy studies and is, therefore, substantially more efficient than ToE while maintaining equivalent scientific rigor. Such efficiency will contribute to the attractiveness as well as the sustainability of biosimilars as a therapeutic modality.
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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 Socratic graph.