Sandoz starts phase III US trial for biosimilar epoetin alfa

Biosimilars/Research | Posted 09/11/2012 post-comment0 Post your comment

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 25 October 2012 that it had started patient enrolment in a phase III clinical trial in the US for biosimilar epoetin alfa (Amgen/Johnson & Johnson’s Epogen/Procrit).

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The study will evaluate the efficacy and safety of Sandoz’s biosimilar epoetin alfa (HX575) versus Amgen’s Epogen in patients with anaemia associated with chronic kidney disease. This new phase III trial is expected to support Sandoz’s goal of registering and launching its biosimilar epoetin alfa in the US.

The trial is a multicentre, double-blind, randomized, active controlled, parallel-group study. Sandoz plan to evaluate the efficacy and safety of weekly subcutaneous injections of HX575 compared with Epogen/Procrit (epoetin alfa) in patients with end stage renal disease over a period of 52 weeks. The trial will be carried out in Texas and has started recruiting patients, aged 18 years and above, in September 2012.  The trial will be completed by September 2014.

Epogen lost its patent protection in the EU in 2004. Sandoz’s biosimilar epoetin alfa was approved in the EU in August 2008. The product has been marketed under the brand name Binocrit since then and has generated more than 160,000 patient years in clinical experience.

It is estimated that more than 600,000 patients in the US are treated for anaemia with epoetin alfa and similar medicines that regulate the formation of red blood cells. Epogen will lose its patent protection in the US in December 2013.

Amgen’s sales of Epogen in 2011 were US$2 billion making it a lucrative target for biosimilars manufacturers.

Sandoz is also currently conducting phase II and III clinical trials for a biosimilar version of Roche’s leading monoclonal antibody Rituxan/MabThera (rituximab) [1], as well as phase III trials with biosimilar filgrastim (Amgen’s Neupogen) and biosimilar pegfilgrastim (Neulasta) [2].

Sandoz already markets biosimilar somatropin (Omnitrope), biosimilar epoetin alfa (Binocrit) and biosimilar filgrastim (Zarzio) in countries across Europe and elsewhere. Omnitrope, approved under the 505(b)(2) pathway of the Hatch-Waxman Act, is also marketed in the US.

Sandoz is the only biosimilars manufacturer to have more than two biosimilars on the market and is set to be a global market leader, with 8–10 molecules at various stages of development [3].

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1.  GaBI Online - Generics and Biosimilars Initiative. Sandoz announces biosimilar rituximab []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Nov 9]. Available from:

2.  GaBI Online - Generics and Biosimilars Initiative. Sandoz starts phase III trials for biosimilar filgrastim and pegfilgrastim []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Nov 9]. Available from:

3.  GaBI Online - Generics and Biosimilars Initiative. Everybody jumping on the biosimilars bandwagon []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Nov 9]. Available from:

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Source:, EMA, Sandoz

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