EMA, European Medicines Agency’s latest list of validated new drug applications shows us that, there’s a biosimilar application for infliximab, the generic name of Merck & Co and Johnson&Johnson’s Remicade.
The European watchdog did not identify the company but according to Reuters, the company is most probably, Celltrion.
Celltrion is a South Korean company and has already declared the positive results of their biosimilar infliximab study. Celltrion has several monoclonal antibody biosimilars in their portfolio and Herceptin, Roche&Genentech’s breast and gastric cancer blockbuster is also their point of interest.
Remicade biosimilar will be the first monoclonal antibody in the European market. Up to now, Europe has approved biosimilar versions of human growth hormones, G-CSFs and Epoetins but no monoclonal antibody biosimilar was registered by EMA yet.
You can check the list of applications which are under review by CHMP from here.