European Medicines Agency organising workshop on biosimilars

25 September 2013

The European Medicines Agency is holding a workshop on biosimilars on 31 October 2013.

The Agency is organising this workshop as part of its public-consultation exercise on its three draft revised overarching guidelines on biosimilars. These are:

• the Draft guideline on similar biological medicinal products, for which written comments are invited until 31 October 2013;
• the Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, for which written comments are invited until 30 November 2013;
• the Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1), for which written comments were invited until November 2012.

The aim of this workshop is to bring together regulators and stakeholders to discuss the three draft revised guidelines, including comments received so far during the public consultation.

Presentations and discussions during the workshop will focus on the main topics identified through the comments received, including:

• the choice of the reference product;
• the concept of quality target-product profile;
• the stepwise approach to non-clinical programme;
• biosimilar-specific clinical models and endpoints.

The workshop will be live-streamed and recorded.