- The FDA has agreed to review Sandoz's biosimilar version of Amgen's Neulasta (pegfilgrastim). Sandoz is the generics unit of Novartis.
- Pegfilgrastim is used to help reduce the risk of infection due to a low white blood cell count in patients with non-myeloid cancer.
- This is the third biosimilar Sandoz has submitted to the FDA. In addition to the biosim of Neulasta, Sandoz received approval for the first-ever approved U.S. biosimilar, Zarxio (filgrastim-sndz), and has also submitted a dossier for consideration of its version of Amgen's Enbrel (etanercept).
In March, Sandoz made history when its biosimilar version of Amgen's Neupogen became the first FDA-approved biosimilar. It now hopes to launch a second biosimilar of an Amgen product into the U.S. market. The company's submission dossier includes three clinical studies which demonstrate the high level of similarity between its version of pegfilgrastim and Amgen's Neulasta.
Keep in mind, however, that approval doesn't mean instant market entry. Although Zarxio was approved by the FDA, it did not launch until September because of a court-imposed injunction due to a patent dispute with Amgen.