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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