Cancer biosimilar drug deemed similar to Neupogen

Novartis AG’s biosimilar cancer drug, EP2006, is “highly similar” to Amgen’s blockbuster cancer drug, Neupogen, FDA staff said in a new report.

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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.

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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.

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“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.