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FDA approves Pfizer's biosimilar of J&J, Amgen anemia drugs

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FDA approves Pfizer's biosimilar of J&J, Amgen anemia drugs

The U.S. Food and Drug Administration approved Pfizer Inc.'s Retacrit, a biosimilar of Johnson & Johnson's Procrit and Amgen Inc.'s Epogen, to treat anemia.

Anemia occurs when blood does not carry enough oxygen to the rest of the body.

Retacrit is also approved for use before and after surgery to reduce the chance of needing red blood cell transfusions due to blood loss during surgery.

The approval is based on a review of data that demonstrated that the drug is a biosimilar to the already approved therapies and not an interchangeable product.

Sales of J&J's Procrit in the U.S. dropped 12% year over year in 2017 to $675 million from $767 million, while Amgen reported a 15% year over year decrease in the U.S. sales of Epogen in 2017 to $1.10 billion from $1.28 billion in 2016.