CRED ERP 25

Marie-Christine Bielsky, Anne Cook, Andrea Wallington, Andrew Exley, Shahin Kauser, Justin L. Hay, 625 Leonard Both, David Brown, Streamlined approval of biosimilars: moving on from the confirmatory 626 efficacy trial. Drug Discovery Today. Volume 25, Issue 11, 2020, Pages 1910-1918, ISSN 1359-6446, 627 https://doi.org/10.1016/j.drudis.2020.09.006. 628 IPRP workshop report 2024: https://admin.iprp.global/sites/default/files/2024- 629 07/IPRP_BWG_Final%20IPRP%20Scientific%20Workshop%20Summary%20Report_2024_0506.pdf 630 FDA 2019 “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and 631 Other Quality-Related Considerations Guidance for Industry”. 632 WHO 2022 “Guidelines on evaluation of biosimilars”. 633 5. List of Abbreviations 634 635 Abbreviation Definition ADCC Antibody-dependent cellular cytotoxicity BMWP (EMA CHMP) Biosimilar Medicinal Products Working Party BWP (EMA CHMP) Biologics Working Party CDR Complementarity Determining Region CES Comparative Efficacy Studies CHMP (EMA) Committee for Medicinal Products for Human Use CQA Critical Quality Attribute MAA Marketing Authorisation Application MoA Mechanism of Action PK Pharmacokinetics PD Pharmacodynamics RMP Reference Medicinal Product WHO World Health Organization WP Working party 636

Reflection paper on a tailored clinical approach in biosimilar development EMA/CHMP/BMWP/60916/2025

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