Drugs

Inspection Violations at Pfizer Plant Places Biosimilar Approval in Limbo

GMP issues cited during a 2016 inspection at Pfizer’s McPherson, KS manufacturing facility (Hospira) have led to a a complete response letter on a BLA for a proposed biosimilar referencing Amgen’s Epogen/Procrit (epoetin alfa). A Warning Letter was issued 2/14 (see earlier story) after FDA conducted a routine inspection 5/10-6/8/16. Issues cited in the Warning Letter included failing to establish valid in-process specifications; failing 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; and failing to control rejected in-process materials under a quarantine system to prevent their use in manufacturing or processing operations for which they are unsuitable.

The Warning Letter also said the facility failed to submit field alert reports to FDA and noted that the agency found similar GMP violations at other facilities in the company’s network. “These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” it said.

The troubled manufacturing facility is listed in Pfizer’s BLA as the manufacturing facility for the biosimilar. However, the company says that the complete response letter noted that the issues uncovered during the inspection did not specifically relate to the proposed epoetin alfa manufacturing, and no additional clinical data were requested for the biosimilar at this time. Pfizer had already submitted a corrective and preventative action plan to FDA in March, and it says it has been diligently working to address the-items outlined in the Warning Letter.

FDA’s Oncologic Drugs Advisory Committee voted 5/25 to recommend approval for the proposed biosimilar. The positive vote was based, in part, on the agency’s briefing materials, which concluded that the proposed biosimilar was highly similar to the reference product.

This was the second complete response letter for the Pfizer-proposed biosimilar. In 2015, the first such letter cited undisclosed issues. At the time, the company said it did not believe any further clinical trials were needed to resubmit the application, which was resubmitted last year.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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