FDA Rejects Proposed Epoetin Alfa Biosimilar for Second Time

A Complete Response Letter cited issues related to violations within a McPherson, KS, facility.

The FDA has rejected Pfizer’s Biologics License Application (BLA) for its proposed epoetin alfa biosimilar for the second time.

In a company press release, Pfizer announced that it received a Complete Response Letter relating to issues noted in a warning letter issued on February 14, 2017, following a routine agency inspection of the company’s facility in McPherson, KS, in 2016.

The facility was listed as the potential manufacturing site in the BLA for the proposed epoetin alfa biosimilar, according to the release.

Several violations were listed in the warning letter from the FDA, including:

  • Failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed. Visible particulates were found in sterile injectable products: vancomycin hydrochloride for injection and ketorolac tromethamine injection.
  • Failure to establish valid in-process specifications.
  • Failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes.
  • Failure to control rejected in-process materials under a quarantine system, to prevent their use in manufacturing or processing operations for which they are unsuitable.
  • Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drugs product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

Five other Hospira plants have been cited in 4 warning letters issued between 2010 and 2015 regarding similar problems. In 2015, Pfizer bought Hospira in a $15 billion deal.

“These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacturer of drugs is inadequate,” the warning letter stated.

The rejection follows a May 2017 vote by the FDA’s Oncologic Drugs Advisory Committee, recommending the proposed biosimilar for approval.

“Pfizer provides regular updates to FDA on the status of its action plan, and remains dedicated to addressing all of FDA’s concerns with McPherson, KS, site,” the press release noted. “The company is committed to making this important treatment option available to patients and physicians as quickly as possible.”