The European Medicines Agency has released a revised
guideline for public consultation describing how
pharmaceutical companies should address the quality aspects of biosimilar medicines.
The guideline updates the previous guidance from 2006, and explains the
requirements for the manufacture and comparability testing for biological
medicines claiming to be similar to another medicine already on the market.
The revised guideline 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.
Comments should be sent to bwp.biosimilar.revision@ema.europa.eu using the form
for submission of comments.