Dutch medicines agency says biosimilars ‘have no relevant differences’ to originators

Biosimilars/General | Posted 10/04/2015 post-comment0 Post your comment

The Dutch Medicines Evaluation Board (MEB) has 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’.

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MEB (College ter Beoordeling van Geneesmiddelen, CBG) is responsible for the approval, i.e. marketing authorization, of medicinal products, including biosimilars, in The Netherlands [1].

MEB had previously – in 2010 – stated that it was ‘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. Moreover, a switch may only occur under the strictest conditions, including the attending physician’s approval’.

The agency’s decision to change this position was based on ‘a careful study of the most recent literature and experiences in the evaluation of biosimilars’. This, says MEB, led it to the conclusion that ‘this strict condition is no longer valid’.

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’.

MEB therefore lists three criteria that represent the agency’s current position on biosimilars:

  • New patients can be treated with a biosimilar right away.
  • Uncontrolled exchange between biologicals (whether originators or biosimilars) must be avoided. In other words, a patient must receive adequate clinical monitoring and clear instructions.
  • If a patient is treated with a biological, detailed product and batch information must be recorded in the patient file to guarantee the traceability of the product in the event of problems.

MEB emphasises that physicians and (hospital) pharmacists should be involved in any decision to switch from one biosimilar to another, so that an informed decision can be taken. The agency adds that ‘cooperation in the area of pharmacovigilance (efficacy and adverse events) is essential’.

MEB also emphasises the importance of intercalating the use of, for example, the new generation of biosimilar therapeutic antibodies in registry studies and performing intensive monitoring, using the Netherlands Pharmacovigilance Centre Lareb. It also emphasises practice-based research as advocated by physician’s organization Federatie Medisch Specialisten (FMS) and the Dutch organization for hospital pharmacists (NVZA – Nederlandse vereniging van ziekenhuisapothekers).

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1.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved and marketed in The Netherlands [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-and-marketed-in-The-Netherlands 

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Source: MEB, Nefarma

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