Zarxio Labeling Updated With New Warning

The FDA has approved Sandoz’s sBLA for the inclusion of glomerulonephritis in the warnings and precautions and postmarketing experience sections of Zarxio, a biosimilar version of Amgen’s chemotherapy drug Neupogen.

The FDA updated Neupogen’s label in July 2015 to reflect the same risk, and Zarxio was approved as the first biosimilar in the U.S. in March 2015.

According to the biosimilar’s label, glomerulonephritis has been seen in patients receiving the treatment, but events resolved themselves following dose reduction or discontinuation of the product.