EC approval granted to Sandoz for subcutaneous route of administration in biosimilar Binocrit's nephrology indication.
M2 PHARMA-April 8, 2016-EC approval granted to Sandoz for subcutaneous route of administration in biosimilar Binocrit's nephrology indication
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Sandoz, a division of Swiss multinational pharmaceutical company, Novartis, that is involved in biosimilars, announced on Friday 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(R) (epoetin alfa) nephrology indication.
Binocrit (epoetin alfa) is a prescription medicine that stimulates the bone marrow to produce red blood cells (anaemia in either the nephrology or oncology setting).
The EU approval was based on data from the SENSE clinical study - an open label, single arm, multicentre study to evaluate 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 Biopharmaceuticals, Sandoz, 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.'
Sandoz has an extensive biosimilar pipeline and plans to make 10 regulatory filings over a three year period (2015-2017) having already submitted five.
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|Date:||Apr 8, 2016|
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