EMA Posts Q&A to Help Drugmakers With Biosimilar Submission Process

The European Medicines Agency (EMA) has published question-and-answer guidance on marketing applications for biosimilars, providing advice on a number of pre-submission 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 the agency’s scientific guidelines on biosimilars, the EMA said Wednesday.
Washington Drug Letter