Therapy Areas: Oncology
FDA Accepts Adello Biologic's Biosimilar Biologics License Application for a Proposed Filgrastim Biosimilar
13 September 2017 - - The US Food and Drug Administration has accepted for review US-based biotechnology company Adello Biologics' Biologics License Application for a biosimilar candidate referencing Neupogen (filgrastim), the company said.

Filgrastim 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.

The BLA submission is supported by similarity data from analytical, pre-clinical and clinical development studies, comparing the biosimilar candidate to Neupogen.

Adello is a privately held, US-based biotechnology company headquartered in Piscataway, New Jersey.

The company is advancing a pipeline of complex proteins and monoclonal antibodies with lead candidates in oncology and immunology.