EMA Updates its Biosimilar Insulin Guideline
By Michael Mezher -
Published 12 March 2015
The European Medicines Agency (EMA) has updated its guideline on the requirements for clinical and non-clinical development of biosimilar insulin products. The update expands the scope of the original document and gives additional detail on study design parameters.
Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Preclinical, Quality, Regulatory strategy, Research and development, Submission and registration
Tags: Biosimilars, guideline, human insulin