Progress on filgrastim biosimilar puts Adello on the map

Privately-held USA-based Adello Biologics has had its Biologics License Application (BLA) for a biosimilar candidate referencing Neupogen (filgrastim) accepted for review by the US Food and Drug Administration (FDA).

Neupogen, marketed by US biotech Amgen (Nasdaq: AMGN), is a short acting granulocyte-colony stimulating factor that increases the body’s production of white blood cells for a number of conditions, including neutropenia in cancer patients receiving myelosuppressive chemotherapy.

Biosimilar versions have been available in the USA since 2015, when Amgen lost in a legal bid to delay a copycat version from entering the market. That allowed Swiss pharma giant Novartis’ (NOVN: VX) generics subsidiary Sandoz to launch Zarxio, its filgrastim biosimilar.