FDA approves First Anemia Biosimilar for Kidney Patients

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The U.S. Food and Drug Administration recently approved Pfizer’s biosimilar anemia drug, Retacrit (epoetin alfa-epbx). After two previous approval attempts, Retacrit was approved as a biosimilar to Epogen (Amgen) and Procrit (epoetin alfa, Johnson & Johnson).

Nephrologists as a group appear to be receptive to biosimilars for their patients. Spherix Global Insights reported their approval in a March 2018 survey of 202 nephrologists, especially if Retacrit use should become required by dialysis organizations. Only 22% of nephrologists surveyed agreed with the statement “I would not be pleased if my dialysis center switched to a biosimilar ESA.”

The biosimilar will be offered later this year at a “significant discount” compared with the current wholesale acquisition cost of the reference product, Epogen, reported BioPharma.

Gaining approval as a biosimilar drug means the biosimilar can be prescribed for anemia in chronic kidney disease (and some other indications).

To receive the biosimilar instead of the reference product, a patient may need a prescription from a healthcare prescriber written specifically for that biosimilar.

In the fall of 2017, the FDA approved the first biosimilar drug indicated for renal cancer. Mvasi (bevacizumab-awwb, Amgen) was approved as a biosimilar to Avastin (bevacizumab, Genentech), according to HealthDay News.