The Netherlands to track switching of biologicals

Home/Policies & Legislation | Posted 10/06/2016 post-comment0 Post your comment

In response to an expected increase in the use of biosimilars in the country, The Netherlands Minister of Health, Edith Schippers, announced on 19 May 2016 the set-up of a national system to monitor the safety of biologicals.

Pharmacovigilance V13F21

Minister Schippers has asked The Netherlands Pharmacovigilance Centre Lareb to set up the monitoring system and has made a fund of Euros 300,000 available for this purpose.

The purpose of the system, according to Minister Schippers, will be to monitor the safety of all biologicals, including biosimilars, and to see how these work in large groups of patients.

Patients will be actively asked to provide information on any adverse effects they experience with the use of biologicals. The agency already collects and analyses reports of adverse reactions of medicines and vaccines through various channels, including its intensive monitoring programme, which also relies on patients to provide information on adverse events.

The system for biologicals – which is said to be unique in the world – will be started in five hospitals in autumn 2016 and will initially follow patients that receive a biological via the hospital. On the basis of the experience gained in this initial trial Lareb will roll out a national system through which they can monitor switches between biologicals and biosimilars. In this way, Lareb expects to strengthen trust in biologicals.

The Dutch Medicines Evaluation Board (MEB) was previously of the opinion that ‘patients must be kept on a biological medicinal product as much as possible if they respond well to it clinically’. It was also reported to be of the opinion that ‘a switch to another biological medicine should be avoided’. However, more recently it updated its position on biosimilars, stating that ‘biosimilars have been proven to have no relevant differences compared to an innovator biological medicinal product as far as quality, safety and efficacy are concerned’. MEB also stated that switching between biologicals (whether originators or biosimilars) ‘is permitted, but only if adequate clinical monitoring is performed and the patient is properly informed’ [1].

Related article
Dutch medicines agency aims to clarify biosimilars confusion

1. GaBI Online - Generics and Biosimilars Initiative. Dutch medicines agency says biosimilars ‘have no relevant differences’ to originators []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 10]. Available from:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2016 Pro Pharma Communications International. All Rights Reserved.

Source: Dutch MoH, Lareb

comment icon Comments (0)
Post your comment
Related content
Generic ‘skinny’ labelling under threat in the US
Label prescription drugs
Home/Policies & Legislation Posted 05/11/2021
FDA publishes final Q&A on biosimilar development and the BPCI Act
Home/Policies & Legislation Posted 15/10/2021
FDA voices concerns around drug patents and competition
Patent 1 V13E17
Home/Policies & Legislation Posted 08/10/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010