Revised guideline on quality of biosimilar medicines open for comments

31 May 2012

The European Medicines Agency has released a Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) 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 [e-mail]