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Objectives <p>This 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.</p> Methods <p>A 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 ≥&#xa0;4.0.</p> Results <p>Overall, 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).</p> Conclusions <p>The consensus-based recommendations identified in this study outline priority areas and measures for streamlining biosimilar development and fostering regulatory convergence.</p>

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Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月21日

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  • Elif Car,
  • Liese Barbier,
  • Ingrid Schwarzenberger,
  • Isabelle Huys,
  • Steven Simoens,
  • Arnold G. Vulto

摘要

Objectives

This 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.

Methods

A 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.

Results

Overall, 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).

Conclusions

The consensus-based recommendations identified in this study outline priority areas and measures for streamlining biosimilar development and fostering regulatory convergence.