Date: 2012-10-25
Type of
information: Initiation of patient enrollment
phase: 3
Announcement: initiation of patient enrollment
Company: Sandoz (Switzerland)
Product: biosimilar epoetin alfa (Binocrit® in the EU)
Action
mechanism: erythropoiesis-stimulating agent/biosimilar. This biosimilar product is a erythropoiesis-stimulating agent.
Disease: anemia associated with chronic kidney disease
Therapeutic
area: Kidney diseases - Renal diseases
Country: USA
Trial
details:
Latest
news:
- • On October 25, 2012, Sandoz has announced that it has started patient enrolment in a late stage clinical trial in the United States for its biosimilar epoetin alfa. The Phase III study will compare safety and efficacy of Sandoz’s biosimilar epoetin alfa with the US-licensed reference product Amgen/Johnson & Johnson’s Epogen® /Procrit® in anemia associated with chronic kidney disease. Sandoz’s biosimilar epoetin alfa has been marketed under the brand name Binocrit® in the EU for over 5 years and has generated more than 160,000 patient years in clinical experience. This new Phase III study will support Sandoz’s goal of registering and launching its biosimilar epoetin alfa in the US.
Is
general: Yes
