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Novartis division begins Phase III clinical trials

Sandoz, a division of the Novartis Group, has initiated two Phase III clinical trials - one for biosimilar Filgrastim in the US market, the other for its global Pegfilgrastim development program.

The Filgrastim study is intended to assess the efficacy and safety of Sandoz’s biosimilar filgrastim versus Amgen’s Neupogen in breast cancer patients eligible for myelosuppressive chemotherapy treatment.

The Pegfilgrastim study is conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment.
Pegfilgrastim is a pegylated form of recombinant human granulocyte-colony stimulating factor (G-CSF).

Sandoz global head, Jeff George said the two development programs demonstrate their efforts to make good on the longer-term promise of their leading pipeline.

Filgrastim biosimilar is currently marketed under the trade name Zarzio in more than 30 countries outside the US.