Dutch medicines agency aims to clarify biosimilars confusion

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Dutch medicines agency aims to clarify biosimilars confusion

Biosimilars/General | Posted 25/09/2015 0 Post your comment

The Dutch Medicines Evaluation Board (MEB) has further clarified its position on biosimilars since its last update in March 2015. The MEB had previously raised concerns among patient groups and professional organizations with the announcement that biosimilars had no relevant differences to originators.

Following discussing with other professionals and patient groups, the Dutch agency has re-emphasized its stand that biosimilars have no relevant differences to originator biologicals in terms of quality, safety and efficacy [1]. However, it noted that several points remain in need of clarification regarding the substitution of biologicals and biosimilars.

Switching between biological medicines is possible, but only with adequate clinical monitoring and sufficient patient information. The MEB is in discussion with a number of patient organizations about developing educational material for patients about biosimilars.

Professional organizations have advised the MEB that questions surrounding the implementation of adequate monitoring and traceability of biologicals (including biosimilars) need to be addressed.

The chairman of the MEB, Professor Bert Leufkens, has thanked these organizations for their input, saying that ‘it is important that everyone knows which product a patient is being treated with and that the clinical effect is being monitored. Therefore, information about the product and batch number should also be recorded in detail in the patient file. This applies to all biological medicines, both innovator products and biosimilars.’

The MEB (College ter Beoordeling van Geneesmiddelen, CBG) is responsible for the approval of marketing authorization of medicinal products including biosimilars in The Netherlands. The Netherland’s first biosimilar, somatropin (Omnitrope), gained maketing approval in 2006 [2].

References

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 2015 Sep 25]. Available from: www.gabionline.net/Biosimilars/General/Dutch-medicines-agency-says-biosimilars-have-no-relevant-differences-to-originators
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved and marketed in The Netherlands [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 25]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-and-marketed-in-The-Netherlands

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Source: MEB