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?

hdl.handle.net/1765/109548
Nederlands Tijdschrift voor Geneeskunde
Erasmus MC: University Medical Center Rotterdam

Vulto, A.G. (2017). Biosimilar geregistreerd, ondanks tegenstem in Europa. Grotere onzekerheid over toegelaten geneesmiddelen in Nederland. Nederlands Tijdschrift voor Geneeskunde, 161. Retrieved from http://hdl.handle.net/1765/109548