Posted 11 April 2012
By Alexander Gaffney
The European Medicines Agency (EMA) released a new regulatory procedure document on biosimilar medicines which it hopes will consolidate a number of regulatory and procedural questions already existing in a number of locations.
The document "complements existing guidance documents on innovative products and should be read in conjunction with the Agency's scientific guidelines on biosimilars," EMA said in a press release.
The document lists 43 questions and answers related to the development and regulatory submission of biosimilar products.
EMA - European Medicines Agency publishes new document on regulatory procedural advice on similar biological medicinesEMA - EMA Procedural advice for users of the centralised procedure for similar biological medicinal products applications