GMP: Monoclonal antibodies as similar biotherapeutic products - Draft Guideline

On 1 March, the World Health Organization (WHO) published a new guideline draft on the evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs). This product specific document is intended to provide special considerations for the evaluation of monoclonal antibodies developed as similar biotherapeutic products and to complement the existing WHO Guidelines like the guidelines on evaluation of similar biotherapeutic products (SBPs) or the guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology.