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].

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

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