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    Green light for biosimilar switching

    26.05.2015 The Finnish Medicines Agency Fimea has joined the Dutch MEB in its stance on the interchangeability of biosimilars. The Fimea now sees physician-driven switching of biologics as unproblematic.

     While small molecule meds can oftentimes be freely switched for generics on the pharmacy level, regulators have been reluctant to allow for the same level in interchangeability as regards biologics. In fact, until now most countries have advised physicians to keep patients on one biologics brand entirely. The Finnish regulator is now the second to have slackened the rules. “The current position of Fimea is that biosimilars are interchangeable with their reference products under the supervision of a healthcare person.” According to them, there is sufficient evidence that switching from one version of a biologic to another is unproblematic. Risk of adverse effects can be expected to be similar to the risk associated with changes in the manufacturing process of any biological product.

    The Dutch Medicines Evaluation Board MEB had already revised its position in March. While it had previously advised that patients on one biologic brand should stick to it, they now say that there is no problem with switching to another biologic version. However, the MEB’s position stipulated that the patient must be informed and remain under proper clinical monitoring.

    Biosimilars still range far from generics in terms of interchangeability. “Automatic substitution at the pharmacy level is not within the scope of his recommendation,” the Fimea stresses.

    Time will tell whether other countries in Europe will now reconsider their own stance on this sensitive topic.


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