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Sandoz wins EU positive opinion for neutropenia drug

Sandoz, a generic drug maker and subsidiary of Novartis, has received a positive opinion from European regulators for its third biosimilar medicine filgrastim, a natural man-made protein produced commercially by recombinant DNA technology, which stimulates production of white blood cells.

Filgrastim is indicated for use in treating neutropenia, a condition characterized by lack of neutrophils – one of the most common types of white blood cells – that is often associated with chemotherapy or bone marrow transplants.

Andreas Rummelt, CEO of Sandoz, said: “The positive opinion from the Committee on Medicinal Products for Human Use is an important first step towards receiving EU regulatory approval. Such approval would provide an important new option, in particular for patients undergoing chemotherapy.

“Filgrastim enables them to stay on their required course of therapy at the optimal dose level by raising neutrophil counts to within the normal range. In addition to significant potential cost savings, our product offers patients and healthcare providers a very pure form of filgrastim.”