Drug news
Pegfilgrastim biosimilar filed with FDA for neutropenia- Sandoz
The FDA has accepted a Biologics License Application (BLA) from Sandoz under the 351 (k) pathway for its pegfilgrastim biosimilar to Amgen's US-licensed Neulasta (pegfilgrastim), a recombinant human granulocyte colony-stimulating factor (G-CSF) indicated for neutropenia.
The submission is based on Phase III PROTECT-1 and PROTECT -2 trials which compared pegfilgastim biosimilar against Neulasta.
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