On 23 December 2005, orphan designation (EU/3/05/340) was granted by the European Commission Novartis Europharm Limited, United Kingdom, for imatinib mesilate for the treatment of myelodysplastic / myeloproliferative diseases. Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2012 on request of the sponsor.
Are biosimilars interchangeable?
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, e.g. 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.
Therefore, the current position of Fimea is that biosimilars are interchangeable with their reference products under the supervision of a health care person.
Biosimilar is a biological medicinal product that has been proven to be similar to its reference product. It can be used in the same therapeutic indications as its reference product. Biosimilars have been marketed in EU since 2006.
Read more:Fimea's position (pdf)Biosimilars
Pekka Kurki, research professor, tel. +358 29 522 3410
E-mail addresses follow the format firstname.lastname@example.org.