Posted by Michael Wonder on 20 Dec 2016
Celltrion’s biosimilar granted marketing approval recommendation in Europe
19 December 2016 - South Korea’s Celltrion Inc., the world’s first developer of a biosimilar version to treat rheumatoid arthritis, is out to make another footprint in the world of copycat versions of biological drugs by adding a cancer biosimilar to its pipeline.
Celltrion said the European Medicines Agency’s CHMP recommended granting marketing authorization to its Truxima (rituximab), a biosimilar to Roche’s Rituxan, which is indicated for blood cancer.
The recommendation issued on last Friday is based on data from various studies that showed Truxima is bioequivalent to its reference drug Rituxan in safety and efficacy.
