European Medicines Agency’s latest list of validated new drug applications shows that, there’s an another biosimilar application for infliximab, the generic name of Merck & Co and Johnson&Johnson’s Remicade.
In April this year, with the publishment of one of the previous applications list, we became aware of the first infliximab biosimilar application. Although EMA do not identify the companies in their reports, it was clear that the company was Korean biosimilar manufacturer, Celltrion.
With this updated list, we can now see increasing number of biosimilar applications in the European area. According to the latest list, EMA has 7 biosimilar applications which are going under review: the list contains 2 infliximab, 3 human insulin, 1 follitropin alfa and 1 filgrastim biosimilars. Just to note, the only biosimilar which was approved in the last three and a half years was Hospira’s filgrastim, Nivestim.
You can check the list of applications which are under review by CHMP from here.