FDA Rejects Neulasta Biosimilar Application

Agency requests reanalysis of subject samples

The FDA has issued a complete response letter (CRL) with regard to a biologics license application for CHS-1701, a biosimilar candidate for pegfilgrastim (Neulasta, Amgen) developed by Coherus BioSciences. The CRL primarily focused on the agency’s request for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and on requests for additional manufacturing-related process information.

The FDA did not request a clinical study to be performed in oncology patients. In addition, the CRL did not indicate that additional process-qualification lots would be required or raise concerns regarding the good manufacturing practice (GMP) status of CHS-1701 bulk manufacturing and fill-finish vendors.

Coherus Biosciences said it will work with the FDA to address the information requests.

Amgen’s pegfilgastrim injection for subcutaneous use is indicated: 1) to reduce the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia, and 2) to increase survival in patients acutely exposed to myelosuppressive doses of radiation (ematopoietic subsyndrome of cute radiation syndrome).

Pegfilgrastim is a covalent conjugate of recombinant methionyl human granulocyte colony-stimulating factor (G-CSF, filgrastim) and monomethoxypolyethylene glycol. Filgrastim is obtained from the bacterial fermentation of a strain of Escherichia coli transformed with a genetically engineered plasmid containing the human G-CSF gene.

Sources: Coherus BioSciences; June 12, 2017; Neulasta Prescribing Information; December 2016.