FDA accepts Sandoz's BLA for biosimilar pegfilgrastim to treat non-myeloid cancer

The US Food and Drug Administration (FDA) has accepted Sandoz's biologics licence application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Neulasta (pegfilgrastim), a recombinant human granulocyte colony-stimulat…
Source: Pharmaceutical Technology - Category: Pharmaceuticals Source Type: news