Finland stands behind interchangeability of biosimilars

June 1, 2015 1:33 PM
The Finnish Medicines Agency Fimea has announced that, it is recommending the interchangeability of biosimilars.

Fimea declares that, the biosimilars licensed in the European Union are interchangeable. Fimea’s recommendation is based on the following items:
  • switches between biological products are common and usually not problematic, e.g. in the context of hospital tendering processes
  • there is currently no evidence for adverse effects due to a switch from a reference product to a biosimilar
  • the theoretical basis of such adverse effects is weak
  • the risk of adverse effects can be expected to be similar to the risk associated with changes in the manufacturing process of any biological product.

Therefore, the current position of Fimea is that biosimilars are interchangeable with their reference products under the supervision of a health care professional.

Fimea’s position can be accessed from here.

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