Greece says no to automatic substitution of biologicals

Biosimilars/News | Posted 15/03/2013 post-comment0 Post your comment

Greece’s Medicines Agency (National Organization for Medicines, Ethnikos Organismos Farmakon, EOF) released a document on 13 March 2013 recommending against automatic substitution/interchangeability of reference biologicals and their biosimilars.

Greece flag V13C15

The document clarifies that the Greek agency does not recommend automatic substitution or interchangeability of biologicals, nor does it recommend the use of international nonproprietary names for biologicals.

The EOF press release was issued in order to clarify instructions for bio-identical pharmaceutical products or biosimilars and states that:

  1. Biosimilars are not suitable for automatic substitution with biological reference products and that there should be no interchangeability between them. This, the agency states, would require a combination of clinical experience and sufficient clinical data.
  2. The EOF recommends prescribing both biological reference products and biosimilars with their brand-name. This, according to EOF, is in order to enable the traceability and safety of patients receiving these products.

In making its decision the EOF has taken into account WHO and EMA guidelines for biosimilars, as well as EC Directive 2012/52/EU on the recognition of medical prescriptions between countries and Greek ministerial decisions.

Editor’s comment

If you would like to receive a copy* of the EOF document, please email us.

*For profit organizations subjected to a fee

Related articles

Biosimilar substitution in the EU

Global guidelines for biosimilars

EU guidelines for biosimilars

Permission granted to reproduce for personal and educational use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: EOF

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010