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 400,000 patient years of experience worldwide. EC approval expands Sandoz biosimilar offering to the healthcare community Holzkirchen, 8 April, 2016 - Sandoz, a Novartis division and the global leader in biosimilars, announced today 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.