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news.Sandoz, the generic pharmaceuticals division of Novartis, has secured approval from the European Commission (EC) for a type II variation for the addition of a subcutaneous (sc) route of administration in Binocrit’s nephrology indication.
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The approval was based on data from the SENSE clinical study, which 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.
Binocrit (epoetin alfa) is a prescription medicine that stimulates the bone marrow to produce red blood cells.
Sandoz epoetin alfa product offering has already generated over 400,000 patient years of experience globally.
Sandoz global head of biopharmaceuticals Carol Lynch said: "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."
In February this year, the European Medicines Agency accepted an application to review Sandoz’s biosimilar to Amgen’s EU-licensed Neulasta (pegfilgrastim) cancer drug.
Sandoz is seeking approval for the similar indication as the reference product.
Earlier this year, Sandoz acquired rights to Pfizer’s PF-06438179, a biosimilar of Merck’s Remicade (infliximab), in the 28-nation European Economic Area.