The European Medicines Agency has published a new document on regulatory procedural advice on similar biological medicines.
The guidance brings together in a single place a number of regulatory and procedural questions already published on the Agency’s website in existing regulatory documents.
It complements existing guidance documents on innovative products and should be read in conjunction with the Agency’s scientific guidelines on biosimilars.
The Agency is responsible for assessing applications from companies to market biological medicines for use in the European Union (EU), including biosimilar medicines within the framework of the centralised authorisation procedure.
European Medicines Agency