Legal Alerts/20 May 2015

Legal Alert – Fimea Issued an Opinion on the Interchangeability of Biosimilars

The Finnish Medicines Agency (“Fimea”) published an opinion on the interchangeability of EU approved biosimilar medicines and their reference medicinal products on 18 May 2015 which is based upon the research of Fimea and experts consulted by it. The opinion is a recommendation for the health care sector.

Fimea’s opinion in short

Fimea concluded that biosimilars are interchangeable with reference medicinal products as long as the change is performed under the surveillance and with the assistance of health care professionals. No opinion is, however, expressed on generic substitution by pharmacies; this opinion concerns solely the interchange between biosimilars and their reference products (and vice versa) under the surveillance of health care professionals.

Biological medicines and biosimilars

Biological medicines contain one or more active substances produced by or derived from a biological source. By definition biosimilar is a biologic medicine which has been developed to be similar to the original biological medicine (“reference medicinal product”) but which contains a new version of the same active pharmaceutical ingredient. When granting a marketing authorization for a biosimilar, the structure, quality, efficacy and safety are compared to the original reference medicinal product by thorough examinations and trials.

Biosimilars are currently widely on the market. According to Fimea, 21 biosimilars have been granted marketing authorizations in the EU by the end of 2014.

Risks of interchange?

According to Fimea, economic interests and overall sustainability of the health care system support the interchangeability of biosimilars. However, there have been some concerns about the effect which the interchange could have on the safety and efficacy of the patient’s treatment.

As a starting point, Fimea assumes that extensive tests and clinical trials have been performed in order to prove that the biosimilar and its reference medicinal product are similar in terms of structure, function, physicochemical characteristics and that pharmacokinetics, effect and safety are similar in at least in one therapeutic indication. Thus the differences in safety and efficacy could be related either to individual differences in pharmacokinetics (not detected) or to immune reactions (unlikely due to the structural similarity and quality demanded of biosimilars).

Fimea notes that the theoretical basis of the risks is rather weak. Moreover, interchanges between non-similar biological medicines are rather common in healthcare, but adverse effects are rarely detected. There is also no evidence of adverse effects of the interchange between reference medicinal products and biosimilars despite the fact that interchanges occur in clinical trials and as a result of tender competitions by hospitals. In Fimea’s opinion, biosimilars with the same reference medicine can be presumed interchangeable, too, although there is no research on the subject. Thus, according to Fimea, there are no more risks involved in the interchange of biosimilars and their reference medicinal products than in the normal changes done in the course of development of biological medicines.

What has changed?

Fimea’s opinion confirms the current situation wherein biosimilars have been widely accepted in the Finnish market. At the same time, Fimea points out the importance of teaching and providing the patient with all necessary information as well as the necessity of documenting the interchange of biosimilars. Fimea’s careful approach is also reflected by the fact that the interchange of biosimilars is allowed to be done only by healthcare professionals.

Please visit Fimea’s website for more information.

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Additional information

Ben Rapinoja