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# FDA Denies Without Comment Apotex Neulasta Petition
- URL: https://www.fdaweb.com/fda-denies-without-comment-apotex-neulasta-petition/
- Published: 2017-10-03T12:00:00.000Z
- Updated: 2026-09-14T22:53:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139766

FDA has denied without comment on whether it will ultimately take any of the requested actions, an Apotex 5/3/17 petition that asked the agency to take four specific actions regarding proposed biosimilars to Amgen’s Neulasta (pegfilgrastim). The denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-2803-0018&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says that because FDA is mandated by law to respond to the petition within 150 days, it must deny it without commenting on whether it will take any of the requested actions.

Apotex said FDA should make the Neulasta biosimilar playing field level by: 

- requiring all biosimilar applicants referencing Neulasta demonstrate no clinical meaningful differences by conducting a comparative clinical efficacy study in at least one of Neulasta’s indicated patient populations;
- requiring all biosimilar applicants referencing Neulasta that intend to rely on comparative clinical pharmacokinetic, pharmacodynamic, and immunogenicity studies in at last one Neulasta patient population to demonstrate **(1)** a correlation in activity between diseased patients and healthy subjects and **(2)** evidence where applicable that the healthy subject data is significantly more sensitive than the representative patient population;
- requiring all biosimilar applicants referencing Neulasta to conduct immunogenicity studies in specified ways; and
- requiring all biosimilar applicants that have not done either of the above three items to withdraw their applications from consideration until the studies have been conducted to meet the criteria.

“FDA has made no final determination on whether to approve or not approve any 351(k) BLA referencing Neulasta,” the agency letter says. “In the case of a 351(k) referencing Neulasta, FDA’s consideration of one or more applications will necessarily inform our decisions on the nature of the data and information necessary to support approval.” The agency does not interpret the law, the letter says, to require that it render a final decision within the statutory deadline on the approvability of a specific aspect of a section 351(k) BLA when a final decision on the approvability of such an application has not yet been made.