EMA Revises Biosimilars Guideline
EMA?s revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.
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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.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
