European Commission approves variation to permit subcutaneous route of administration in Binocrit's (epoetin alfa) nephrology indication.- Sandoz
Sandoz, 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.
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 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.
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