You are here

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.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks