News | April 8, 2016

Sandoz Receives EC Approval For Subcutaneous Route Of Administration In Biosimilar Binocrit's Nephrology Indication

  • Sandoz’ epoetin alfa product offering has already generated more than 400,0001 patient years of experience worldwide
  • EC approval expands Sandoz biosimilar offering to the healthcare community

Sandoz, a Novartis division and the global leader in biosimilars, announced recently that the European Commission (EC) has approved a type II variation for the addition of a subcutaneous (s.c.) route of administration in Binocrit’s (epoetin alfa) nephrology indication*.

“By expanding our biosimilar offering to the healthcare community, the EC approval of a subcutaneous route of administration for use in our Binocrit’s nephrology indication will mean more choice for healthcare professionals as well as increased convenience for patients” said Carol Lynch, Global Head Biopharmaceuticals, Sandoz.

The EU approval was based on data from the SENSE clinical study - an open label, single arm, multicenter study to evaluate the safety and immunogenicity of HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in pre-dialysis and dialysis patients.

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars and currently markets three biosimilars. Sandoz has a leading biosimilar pipeline and plans to make 10 regulatory filings over a three year period (2015-2017) having already submitted five. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

About Binocrit
*Binocrit (epoetin alfa) is a prescription medicine that stimulates the bone marrow to produce red blood cells (anemia in either the nephrology or oncology setting).

For Binocrit’s approved indications and the EU summary of product characteristics including the labelled safety information please visit here at

About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars, driving sustainable access to high-quality healthcare. Sandoz supplies a broad range of affordable, primarily off-patent products to patients and customers around the globe. The Sandoz portfolio comprises approximately 1,100 molecules, which accounted for 2015 sales of USD 9.2 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area. The company holds leading global positions in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines.

1. Periodic Safety Update Report, PSUR P7: Period until 31 Aug 2015, Date of Report: 22 Oct 2015 

Source: Sandoz