Sandoz files pegfilgrastim biosimilar at EMA for the same indication as the reference product Neulasta.

Sandoz has announced that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for its biosimilar to Amgen's EU-licensed Neulasta (pegfilgrastim) - a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product. That is, to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; and to increase survival in patients acutely exposed to myelosuppressive doses of radiation, or hematopoietic subsyndrome of acute radiation syndrome.

Sandoz believes that the totality of evidence in its submission, including three pivotal clinical trials - one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients - is expected to satisfy the regulatory requirements for demonstrating high similarity to the reference product and therefore justifies use of biosimilar pegfilgrastim in the reference product's indication.

Comment: Neulasta (pegfilgastim) patents in US expired in 2015 and the European patents expire in August 2017.