Fimea to survey the views of pharmaceutical operators on the generic substitution of biological medicines

Fimea will survey the views of pharmaceutical operators on the generic substitution of biological medicines. The purpose of the survey is to obtain a broad-based view of the pharmaceutical operators concerning issues related to the potential generic substitution of biological medicines, in particular from the point of view of safeguarding medication safety.

Fimea’s statutory duties include creating and maintaining a list of interchangeable medicines that are biologically equivalent and whose active substance and concentration are the same. The list serves as a basis for the generic substitution that takes place at pharmacies.

In Finland and in the majority of EU Member States, biosimilars and their biological reference medicines are not currently included in the scope of the generic substitution that takes place at pharmacies. However, there is an increasing international interest towards generic substitution of biological medicines, but the means for safely carrying out generic substitution remain to be mapped out.

Biological medicines involve high and constantly increasing costs. The introduction to market and uptake of biosimilars will initiate price competition between biological preparations, balance out the cost increase, and reduce the sustainability gap in public finances without impairing the effectiveness of pharmacotherapy.

The Rational Pharmacotherapy Action Plan examined ways and means to support the prescription of more affordable biological medicines that are used in ambulatory care. Additionally, both information-based and regulatory guidance has been provided. However, according to the experience gained, the use of biosimilars in ambulatory care has remained sparse. Furthermore, the introduction to market of biosimilars is slow in Finland compared to the other Nordic countries.

In the survey, pharmaceutical operators will be interviewed and the operating models implemented in other European countries will be examined. The interviews of the operators are planned to take place during next autumn.

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Biosimilars

Fimea’s opinion on the interchangeability of biosimilars

Publications and reports of the Rational Pharmacotherapy Action Plan

Working group report of the Rational Pharmacotherapy Action Plan: Rational prescribing, dispensing and use of medicines in current and future healthcare and social welfare structures