EMA Biosimilars Q&A Aims to Clarify Presubmission Issues, Review Timelines

The European Medicines Agency (EMA) has published a question-and-answer guideline on marketing applications for biosimilars, providing advice on a number of presubmission issues, such as requesting an accelerated assessment, and giving detailed answers about review timing. The guidance collects various regulatory and procedural questions already published on the EMA’s website and should be read in conjunction with its scientific guidelines on biosimilars, the agency said April 11.
International Pharmaceutical Regulatory Monitor