October 2025 saw the 81st meeting of the World Health Organization (WHO) Expert Committee on Biological Standardization (ECBS) held from 13 to 16 October in Tunis, Tunisa (and virtually) [1].
The ECBS discussed issues regarding the quality, safety and efficacy of biological products used in medicine. It also received updates on the activities of custodian laboratories for the highly specialized WHO measurement standards used in biological development and manufacture.
During the meeting, WHO made a formal recommendation to adopt the ‘WHO Guidelines on the replacement or removal of animal tests for the quality control of biological products’ [2, 3]. This move aligns with current global regulatory progress and underscores WHO’s commitment to supporting manufacturers and regulators in accelerating the shift to scientifically justified, non-animal in vitro alternatives for quality control.
Additionally, the ECBS recommended the establishment of six replacement and 11 new WHO international reference standards for vaccines, biotherapeutics, in vitro diagnostics, and other critical blood products, as outlined in [4]. These standards would cover biotherapeutics such as ranibizumab and anti-drug antibodies to adalimumab for use in binding assays, neutralization assays, and the detection of low-activity ani-drug antibodies to adalimumab.
These WHO resources are the basis of international standardization efforts that are key to ensuring the equitable availability of safe and effective biological products worldwide.
A full meeting report will be published in the WHO Technical Report Series in 2026.
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References
1. who-guidelines.animal-testing.final.pdf
2. GaBI Online - Generics and Biosimilars Initiative. Advances in EMA plans to streamline biosimilar assessment [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 7]. Available from: www.gabionline.net/guidelines/advances-in-ema-plans-to-streamline-biosimilar-assessment
3. GaBI Online - Generics and Biosimilars Initiative. EU steps closer to the ‘tailored approach’ for biosimilars development[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 7]. Available from: www.gabionline.net/reports/eu-steps-closer-to-the-tailored-approach-for-biosimilars-development
4. ECBS%20Executive%20summary.final.IK.21_Oct_2025$2025-10-21-10-16-10~.docx
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