Biosimilar geregistreerd, ondanks tegenstem in Europa

On 1 April 2016 the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a new biological medicine, Flixabi^®, a biosimilar to infliximab (Remicade^®); however, in the appendix of the European Public Assessment Report (EPAR) it appeared that an important minority (14 of 33 votes) opposed this decision, among them the Netherlands representative. In an original article, the Dutch Medicines Board (CBG-MEB) explained the reason for this decision, but still allowed the drug on the market. This commentary states that the EPAR is a ‘snapshot’, without the option for an update once the level of uncertainty has been reduced and the drug is more acceptable. This confronts the prescribing physician with an uncertain situation: which drugs can be safely prescribed and which drugs may not be supported by the CBG-MEB?

Conflict of interest and financial support for this article: the author is an advisor for various pharmaceutical companies and takes part in continued education sessions, which are supported by pharmaceutical companies such as AbbVie, Amgen, Biogen, Boehringer-Ingelheim, Medicines-for-Europe, Mundipharma, Novartis/Sandoz/Hexal, Pfizer/Hospira and Roche. Remuneration is always paid to his employer, the Erasmus Medical Centre in Rotterdam, the Netherlands; he does not have any financial interest himself in these consultancy or speaking arrangements. The author is one of the initiators of an independent research fund (the MABEL fund) at the Catholic University (KU) Leuven, Belgium, which is remotely supported by a consortium of pharmaceutical companies.