EMA Seeks Feedback to Guideline on Biosimilar Similarity Rules

The European Medicines Agency (EMA) has issued revisions to a 2006 biosimilar guideline which clarify clinical and nonclinical requirements for marketing such products. Since the reference-listed drug has already proven efficacy, the draft guideline details other purposes for efficacy trials and how investigations can illuminate significant differences between the reference and biosimilar products.
International Pharmaceutical Regulatory Monitor