Sandoz’s Pegfilgrastim Biosimilar Application Accepted by the FDA

Yesterday, Sandoz announced that the FDA has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim).  This is the second of ten proposed regulatory filings Sandoz has promised to make over the next three years (the first of which is already on the market, as discussed here).

Pegfilgrastim stimulates the growth of white blood cells in a human body; it is used to reduce the chance of infection caused by a low white blood cell count in cancer patients receiving chemotherapy.  To prove that the proposed biosimilar is highly similar to the reference product, Sandoz submitted three pivotal clinical trials, one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients.

Stay tuned to the Big Molecule Watch for updates on Sandoz’s submissions.