Biosimilars are interchangeable, says Finland's regulator

26 May 2015

The Finnish Medicines Agency, Fimea, has presented its position towards interchangeability of biosimilars licensed in the European Union. The position is a recommendation to the local health care system.

It has been argued that a switch from an original biological medicinal product (reference product) to its biosimilar copy is risky. The recommendation of Fimea concludes that:

switches between biological products are common and usually not problematic, eg, in the context of hospital tendering processes;
for time being, there is no evidence for adverse effects due to the switch from a reference product to a biosimilar;
the theoretical basis of such adverse effects is weak;
risk of adverse effects can be expected to be similar to the risk associated with changes in the manufacturing process of any biological product; and
automatic substitution at the pharmacy level is not within the scope of this recommendation.

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