Rational Pharmacotherapy Action Plan promotes the adoption of biosimilars

Ministry of Social Affairs and Health 24.10.2016 12.34 | Published in English on 31.10.2016 at 9.46
News item

As part of the Government's Rational Pharmacotherapy Action Plan, a plan has been drawn up to promote the adoption of biosimilars in Finland. The purpose of this is to reduce the costs arising from biological medicinal products, without compromising the effectiveness of pharmacotherapy for patients. The plan supports the implementation of legislative reforms being planned in order to promote the adoption of biosimilars. This includes measures such as increasing prescribers’ knowledge of biosimilars and engaging operators in drawing up instructions suitable for their own needs in order to ensure safe interchange.

Biological medicinal products are rapidly gaining ground in pharmacotherapy. The top 10 medicinal substances causing the highest medicine reimbursement expenditure include six biological reference medicines, which account for 16 per cent of such expenditure.

A biosimilar is a biological medicine developed to be similar and comparable to a biological reference product. Biosimilars contain the same active substance as the reference product, but a different version of it.

The clinical development programme for a biosimilar does not have to be as extensive as for the reference product, which can mean that the biosimilar has a lower market price.  However, extensive analytical and clinical comparisons are performed to ensure that biosimilars with marketing authorisations are comparable – with respect to their approved therapeutic indications – to their reference product in terms of quality, efficacy and safety. Biosimilars have been on the EU markets for a decade and none have had to be withdrawn due to problems with their efficacy or safety.

The Rational Pharmacotherapy Action Plan is one of projects listed in the Government Programme of Prime Minister Juha Sipilä. The objective of the Action Plan is to improve the overall treatment and functional capacity of patients, and to create a framework for using pharmacotherapies that are cost-effective from the perspective of both the patient and society. The Ministry of Social Affairs and Health is in charge of the Action Plan. The Social Insurance Institution of Finland (Kela), THL, the National Supervisory Authority for Welfare and Health Valvira, the Association of Finnish Pharmacies, the Finnish Medical Association, the Finnish Pharmacists' Association, Duodecim and various patient associations are involved in the implementation of the programme. The Finnish Medicines Agency Fimea is coordinating the implementation of the plan promoting the adoption of biosimilars.

Further information

Liisa-Maria Voipio-Pulkki, Director of Health Care, tel. +358 2951 63382, [email protected]
Liisa Siika-aho, Director, tel. +358 2951 63085, [email protected]
Päivi Ruokoniemi, Senior Medical Officer, tel. +358 2952 23442, [email protected] (N.B. no Scandinavian letters å, ä or ö)