Novartis AG’s biosimilar cancer drug, EP2006, is “highly similar” to Amgen’s blockbuster cancer drug, Neupogen, FDA staff said in a new report.
FDA’s Oncologic Drugs Advisory Committee considered the report findings when they met on January 7 to determine whether EP2006 should be approved for all 5 conditions that Neupogen treats.
In the report, FDA staff found that the biosimilar should be approved for all 5 conditions. “The FDA review of the data from Cycle 1 of EP06-302 study supports the Applicant’s contention that there are no clinically meaningful differences between EP2006 and US-licensed Neupogen…” the report stated.
Sandoz submitted 2 clinical studies that evaluated efficacy and safety end points in support of the licensure of EP2006. One study (EP06-301) was a non-comparative single arm study in which patients with breast cancer were treated with chemotherapy and then 1 day later were given daily EP2006 until neutrophil recovery.
The other study, EP06-302, the primary study, enrolled women with breast cancer undergoing chemotherapy. In the study, 96.3% of the 213 patients experienced at least 1 adverse event, the majority of which were suspected to be related to chemotherapy with no difference among the arms.
“The number of adverse events which were suspected to be due to EP2006 or US-licensed Neupogen products was not different between the various arms of EP06-302. Only one AE led to study discontinuation, which was a patient with blood pressure fluctuation which occurred following US-licensed Neupogen,” the report stated.
“Taken together in considering the totality of the evidence, the data submitted by the Applicant…[suggest] that EP2006 should receive licensure for each of the five indications for which Neupogen is currently licensed,” the report stated.