Sandoz begins phase III studies in the United States for biosimilar epoetin alfa

Holzkirchen, Germany, 3-11-2012 — /europawire.eu/ — Sandoz, the global leader in biosimilars, 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 experience¹. 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. “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®).

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About Sandoz

Sandoz, a Division of the Novartis group, is the second-largest generic pharmaceuticals company globally, offering a broad range of about 1,000 high-quality, affordable products that are no longer protected by patents. With approximately 25,000 employees in 140 countries, Sandoz holds the #1 position globally in biosimilars as well as generic injectables, ophthalmics, dermatology, and antibiotics. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments, and hormone therapies. Sandoz develops, produces, and markets these medicines along with pharmaceutical and biotechnological active substances and anti-infectives. In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US). In 2011, Sandoz posted sales of USD 9.5 billion.

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For further information

Sandoz Global Communications:

Sreejit Mohan
+49 8024 4762550

¹: Sandoz internal data