ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2025
Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
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Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThis study aims to assess perspectives of stakeholders on scientific and regulatory challenges associated with biosimilarity demonstration and to formulate consensus-based recommendations to foster regulatory convergence and streamline biosimilar development globally.
methodsA modified Nominal Group Technique with an international panel of regulators, academics, and industry representatives involved three phases: (i) first individual grading, (ii) focus group discussions, and (iii) second individual grading. High consensus was defined as ≥80% agreement with a weighted mean score of ≥ 4.0.
resultsOverall, four focus groups were held in September 2023 with 21 participants (2 academics, 7 regulators, and 12 industry representatives). In total, 22 recommendations were proposed, with 16 obtaining high consensus. Highest-rated recommendations included enhancing stakeholder education on science-based biosimilarity principles (mean score: 4.65/5), promoting regulatory convergence through reliance (mean score: 4.65/5), aligning regulatory requirements based on current scientific knowledge (mean score: 4.60/5), reconsidering the requirement for comparative clinical efficacy studies (mean score: 4.65/5), harmonizing reference product selection criteria (mean score: 4.55/5), facilitating proactive knowledge sharing among regulators (mean score: 4.50/5), eliminating in vivo animal studies (mean score: 4.50/5), and accepting clinical studies conducted for global submissions (mean score: 4.50/5). Two recommendations received the lowest consensus: providing incentives for the development of new pharmacodynamic biomarkers (mean score: 2.80/5) and developing distinct International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines for biosimilar assessment (mean score: 3.20/5).
conclusionsThe consensus-based recommendations identified in this study outline priority areas and measures for streamlining biosimilar development and fostering regulatory convergence.
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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.