EMA receives an another infliximab biosimilar filing

September 21, 2012 11:07 AM

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.

Leave a Reply

Twitter ID
(ID only. No links or "@" symbols)

Latest News on Biosimilar News

Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?


Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!