FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Rejects Coherus’ Neulasta Biosimilar, Calls for New Sample Analyses

June 16, 2017

The FDA rejected Coherus Bioscience’s proposed biosimilar for Amgen’s Neulasta, Coherus announced.

In a complete response letter, the agency denied Coherus’ aBLA for the company’s biosimilar candidate, requesting a re-analysis of certain subject samples, as well as further manufacturing-related process information.

The agency did not call for a clinical trial or for further process qualification lots, according to Coherus.

Coherus pledged to work with the agency to fulfill the requests. President and CEO Denny Lanfear noted that the company was particularly encouraged that the FDA did not request a patient study and expressed hope that the firm could meet with the agency to establish a concrete path for the candidate in coming months.

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