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.
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:
- 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.
- 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.
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Source: www.gabionline.net
