European Medicines Agency (EMA) goes one step forward about biosimilars and invites feedback on plans to revise existing guidelines on biosimilar medicines.
As well known, Europe has the most regulated biosimilars market in the world. Europe’s regulatory watchdog, EMA (formerly EMEA) has published guidelines and approved several biosimilars till today. Additionally, EMA has also completed their preparations about biosimilar monoclonal antibodies guideline which will soon be published.
Now, the European Medicines Agency published a concept paper to start the three-month consultation period about the revision of the guideline of biosimilars. The deadline for comments is the last day of 2011 and the revised guideline will be published during the year 2012.
If you want to have look at the concept paper which asks for advice about clinical and non-clinical issues, you can click the link below: