FDA Accepts Adello Biologics’s Biosimilar Biologics License Application For A Proposed Filgrastim Biosimilar
Published: Sep 11, 2017
PISCATAWAY, N.J.--(BUSINESS WIRE)--U.S.-based Adello Biologics today announced that U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for a biosimilar candidate referencing Neupogen® (filgrastim).
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.
“At Adello, our vision is to provide high-quality, affordable biosimilars to patients,” said Dr. Peter Moesta, chief executive officer of Adello. “If approved, we are excited to be able to offer an additional, important treatment choice that can prevent serious complications for patients.”
The BLA submission is supported by similarity data from analytical, pre-clinical and clinical development studies, comparing the biosimilar candidate to Neupogen®.
About Adello Biologics LLC.
Adello is a privately held, U.S.-based biotechnology company headquartered in Piscataway, NJ. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Driven by a team of highly skilled industry veterans, Adello is advancing a pipeline of complex proteins and monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit adellobio.com.
Learn more about biosimilars: http://adellobio.com/about-biosimilars/.
Neupogen® is a registered trademark of Amgen Inc.