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Sandoz Receives EC Approval for Biosimilar

August 31, 2007

German generics manufacturer Sandoz, a division of Novartis, has become the first company to develop and receive European Commission (EC) approval for its biosimilar epoetin alfa, a treatment to regulate the formation of red blood cells.

The EC’s  decision to grant this approval followed a positive opinion in June from the European Medicines Agency’s Committee on Medicinal Products for Human Use.
 
According to Sandoz, the approval was indicated for the use of biosimilar epoetin alfa in treating patients with renal anemia as well as those receiving chemotherapy.