Module 9 2024

03/09/2024

Nonclinical testing of biologics Post-FIH Testing

Once all the data are available, it’s time to request permission to market the drug :

• Biologics Licence Application (BLA; US)

• Marketing Authorisation Application (MAA; EMA)

The Organisation for Professionals in Regulatory Affairs

Preclinical Testing of Biologicals – Sept 2024

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Nonclinical testing of biologics Some Key Regulatory Guidelines

• ICH S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (2010)

• ICH S9 : Nonclinical Evaluation of Anticancer Pharmaceuticals (2009)

• ICH S8 : Immunotoxicology Studies (2005) → Proposed for update

• ICH M3 (R2): Non-clinical safety studies for the conduct of human clinical trials with pharmaceuticals (2009) • EMA : Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products (2018) EMEA/CHMP/SWP/28367/07 Rev. 1

• EMA : Guideline on Immunogenicity assessment of therapeutic proteins (2017) EMEA/CHMP/BMWP/14327/2006 Rev 1

• FDA : Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (2005) • FDA : Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody (2019)

• FDA : Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals (2023)

The Organisation for Professionals in Regulatory Affairs

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