Sandoz receives EU approval for subcutaneous injection of Binocrit biosimilar

pharmafile | April 8, 2016 | News story | Medical Communications, Research and Development Sandoz, binocrit, biosimilar, eu approval 

Sandoz has received approval from the European Commission for a type II variation for the addition of a subcutaneous route of administration in Binocrit’s (epoetin alfa) nephrology indication.

This approval is based on data from the SENSE clinical study which evaluated the safety and immunogenicity of HX575 epoetin alfa in the treatment of anaemia associated with chronic kidney disease in pre-dialysis and dialysis patients.

Carol Lynch, global head of biopharmaceuticals at Sandoz, says: “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.”

Sean Murray

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