EMA Revises Biosimilars Guideline

Jun 11, 2013
By Pharmaceutical Technology Editors

The European Medicines Agency (EMA) has revised their guideline on clinical and nonclinical issues related to biosimilars that contain biotechnology-derived proteins. The guideline includes requirements for marketing authorization of a biosimilar claiming to be similar to a biological product already marketed. The revised guideline updates the previous 2006 guidance and is open for public consultation for six months.

The revision provides additional guidance on the risk-based approach for the design of non-clinical studies; the use of pharmacodynamic markers for the demonstration of clinical comparability; study design (non-inferiority versus equivalence), choice of an appropriate patient population, and choice of surrogate endpoints in efficacy trials; the design of immunogenicity studies; and extrapolation of efficacy and safety from one therapeutic indication to another.