EC OKs New Route of Administration for Sandoz’s BinocritBy
Sandoz, a Novartis division, reports that the European Commission (EC) has approved a Type II variation for the addition of a subcutaneous (s.c.) route of administration in the Binocrit’s (epoetin alfa) nephrology indication. Binocrit is a biosimilar of epoetin alfa that stimulates the bone marrow to produce red blood cells (anemia in either the nephrology or oncology setting).
Sandoz currently markets three biosimilars. It plans to make 10 regulatory filings over a three-year period (2015-2017) having already submitted five.