Sandoz 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.
It is estimated that more than 600,000 patients in the US are treated for anemia with epoetin alfa and similar medicines that regulate the formation of red blood cells.
“This latest study further reinforces Sandoz’s strong commitment to increasing access to high-quality, affordable biopharmaceuticals and further expanding our biosimilars business”, said Ameet Mallik, Head of Biopharmaceuticals and Oncology Injectables.
Mallik continued, “Sandoz is looking forward to bringing the benefits of a high-quality, safe, effective and affordable epoetin alfa to patients, physicians and payors in the US.
Sandoz continues to enroll patients and make progress on its other ongoing Phase II and III trials for rituximab (Roche’s Rituxan®/Mabthera®) and Phase III trials with filgrastim (biosimilar Neupogen® and pegfilgrastim (biosimilar Neulasta®).