Neulasta Biosimilar to Be Reviewed by FDA
The Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for CHS-1701, a pegfilgrastim biosimilar candidate from Coherus BioSciences.
Pegfilgrastim is currently marketed under the brand name Neulasta (Amgen). Neulasta is indicated 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. It is also approved to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 to Neulasta.
The biosimilar user fee act (BSUFA) action date has been set for June 9, 2017.
For more information visit Coherus.com.