Draft guideline on biosimilar medicines containing monoclonal antibodies released for consultation

26/11/2010

Draft guideline on biosimilar medicines containing monoclonal antibodies released for consultation

26/11/2010 - The Agency has released the draft guideline on similar biological medicinal products containing monoclonal antibodies for a six-month consultation period.

The guideline lays down the requirements for medicines containing monoclonal antibodies that claim to be similar to another such medicine already marketed.

Comments on the draft guideline can be submitted to the Agency up to 31 May 2011.

The Agency has also released a related guideline on the immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use for consultation until the same date.

For more information, see:

• the draft guideline on similar biological medicinal products containing monoclonal antibodies;
• the draft guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use.