The US Food and Drug Administration has agreed to review Novartis unit Sandoz’ pegfilgrastim – a biosimilar to Amgen’s Neulasta and its third biosimimilar now filed in the country.
Pegfilgrastim is used to help reduce the risk of infection due to a low white blood cell count in patients with non-myeloid cancer who receive chemotherapy, which can cause fever and a low blood cell count (febrile neutropenia).
Sandoz is seeking approval for the same indication as the reference product, and says it believes that the totality of evidence in its submission, including three pivotal clinical studies, “will demonstrate that the proposed biosimilar is highly similar to the reference product”.
The company launched the first ever biosimilar – Zarxio, a copycat version of Amgen’s Neupogen (filgrastim) – on the US market in September, and the FDA is also currently reviewing its biosimilar of Amgen’s autoimmune disease drug Enbrel (etanercept).
