12:00 AM
Sep 03, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

TevaGrastim filgrastim regulatory update

FDA approved a BLA from Teva for tbo-filgrastim (XM02) to treat severe neutropenia in patients with non-myelogenous malignancies receiving chemotherapy. The human granulocyte colony-stimulating factor (G-CSF) was approved under section 351(a) of the Public Health Service Act and therefore is not considered a biosimilar of Neupogen filgrastim, a granulocyte-colony stimulating factor (G-CSF)...

Read the full 259 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Week In Review

Article Purchase

$35 USD
More Info >