FDAnews Drug Daily Bulletin

FDA Committee Recommends Hospira’s Epogen/Procrit Biosimilar for Approval

June 1, 2017

An FDA advisory committee endorsed Hospira’s biosimilar version of Epogen and Procrit, used to stimulate the production of red blood cells.

The Oncologic Drugs Advisory Committee voted 14-to-1, recommending approval in three indications in treating anemia, including following chemotherapy, and in reducing the need for red blood cell transfusions. Currently, Hospira is not seeking an interchangeability designation.

Epogen (epoetin alfa), developed by Amgen, was first approved in 1989. Along with the company’s related product, Aranesp (darbepoetin alfa), the two totalled over $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.

Hospira, a Pfizer company, first submitted its epoetin aBLA in 2015, which was subsequently rejected by the FDA before resubmission in December 2016. The product uses the same cell production lines, growth medium and purification processes as Hospira’s Eprex biosimilar Retacrit, approved in the EU since 2007, and was found to be structurally similar.

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