Sandoz, a Novartis division, has announced 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.