The European Medicines Agency (EMA) announced yesterday that, it has released a revised guideline for public consultation describing how pharmaceutical companies should address the quality aspects of biosimilar medicines.
This guideline will update the previous guidance from 2006 and it explains the requirements for the manufacture and comparability testing for biological medicines claiming to be similar to another medicine already on the market.
The 31 May guidance was adopted by the Agency’s Committee for Medicinal Products for Human Use (CHMP) in May 2012. It is open for consultation until the end of November 2012.
The revised guideline can be accessed from here: