EMA Revises Biosimilars Guideline

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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.