FDANews
The QMN Weekly Bulletin

Hospira’s Epoetin Biosimilar Delayed Following CRL Over GMP Violations

June 30, 2017

Pfizer and its generic injectables arm, Hospira, received a complete response letter for their proposed biosimilar of epoetin alfa, also known as Epogen and Procrit, following manufacturing issues cited in a February FDA warning.

The warning letter was issued following a routine FDA inspection of a McPherson, Kan., Hospira facility in spring 2016, listing significant GMP violations for finished pharmaceuticals, though unrelated to the production of epoetin.

In its warning letter, the FDA said the facility did not thoroughly investigate unexplained discrepancies in batches or components; failed to establish valid in-process specifications, or follow written contamination prevention procedures; nor establish appropriate laboratory controls.

In addition, rejected in-process materials were not kept under a quarantine system to prevent re-use. The agency highlighted similar GMP violations at Hospira’s facilities in India, Italy and Australia, as well as two U.S. locations.

The FDA did not request additional clinical data in its CRL. Indeed, Hospira’s epoetin biosimilar received a favorable advisory committee evaluation last month, gathering recommendations for approvals in three anemia indications, including following chemotherapy and in reducing the need for red blood cell transfusions.

Epogen, developed by Amgen, was first approved in 1989. Along with the company’s related product, Aranesp (darbepoetin alfa), the two totaled more than $3.3 billion in global sales last year. Meanwhile, Johnson & Johnson’s identical licensed version, Procrit — sold in the European Union as Eprex — brought in $1.1 billion worldwide.

Pfizer submitted a corrective and preventive action plan to the FDA in March and has been working to address the items outlined in the warning letter, the company said.

Hospira, acquired by Pfizer in 2015, has had several issues in maintaining sterility, recently recalling 59 lots of injectables distributed over the past six months.

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