Tuesday, April 17, 2012

Remicade ( Infliximab) biosimilar filed in EU

Celltrion submits application to EMA for biosimilar infliximab  (Remicade)


Celtrion has submitted a regulatory application to EMA for a biosimilar version of autoimmune drug infliximab. According to EMA, this is the first application submitted for a biosimilar mAb. The product is partnered with Hospira Inc. Merck has EU, Russia and Turkey rights for Remicade, together which is about $2.3b in annual sales. JNJ receives about 50% of the profit share from sale by Merck.