Module 5 Presentations

16/07/2024

Two Primary Differences between Biopharmaceuticals and NCEs

Potential Immunogenicity • Must assess potential immune response to biopharm agent • No reliable translation of response from animals to humans • Need to classify type of antibody (i.e. neutralising vs non-neutralising) • Neutralising antibodies could be reason for change in either efficacy or pharmacokinetic profile • Relevant to interpretation of animal and human results • Antibodies to even completely human mAb’s have been seen in clinical trials

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

43

FDA and Expedited Safety Reports – Dec 2012

Animal studies or in vitro studies • Clinical or investigations • Reports in the scientific literature • Unpublished scientific papers • Information presented at scientific meetings • Reports from foreign regulatory authorities • Reports from commercial marketing experience • Safety information presented at a professional meeting • Foreign spontaneous reports epidemiological

FDA Guidance - Safety Reporting Requirements

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

44

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