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Biosimilars Law Blog
Posted in Global Comparisons, News & Events

Netherlands MEB revises position on biosimilars and interchangeability

The Dutch Medicines Evaluation Board (MEB) published a new position on biosimilars, in which it accepts substitution or interchangeability of biosimilars under certain conditions.

The MEB’s revised position on biosimilars was published on 31 March 2015 and replaces its previous position of 2010. The 2010 position provided that patients should be kept at the same biological medicinal product if the patient responded well to such biological medicinal product. The MEB now considers that substitution of one biological medicinal product for the other – both for originator biological and biosimilar medicinal products – is possible, provided that the substitution is adequately clinically monitored and that the patient is well informed.

This results in the following new position of the MEB:

  • New patients can be prescribed with a biosimilar medicinal product without further ado.
  • Uncontrolled substitution between biological medicinal products – irrespective of whether it concerns an originator biological medicinal product or a biosimilar – should be avoided. This means that a patient should be informed about the substitution and that substitution should be adequately clinically monitored.
  • The patient file of a patient that is treated with a biological medicinal product should contain information regarding the biological medicinal product, including the batch number of such product in order to ensure that the product can be traced if problems should occur.

The MEB further informs that it is necessary that both the treating physician and the pharmacist are involved when one biological medicinal product is substituted for another in order to ensure that such decision is taken with due care. The MEB stresses that collaboration regarding pharmacovigilance is essential in this respect.