EMA Revises Biosimilars Guideline - - BioPharm International

ADVERTISEMENT

EMA Revises Biosimilars Guideline


RELATED ARTICLES

More in GMPs/Validation

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.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

J&J Speeds Ebola Vaccine Development and Expands Production
October 24, 2014
Despite AbbVie Snub, Shire Says it Will Double Sales by 2020
October 24, 2014
Manufacturing Challenges of mAb Production: CHO or Plant Cells?
October 24, 2014
Celgene and Sutro Partner on ADC Development
October 24, 2014
GSK Accelerates Ebola Vaccine Development
October 24, 2014
Author Guidelines

Click here