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FDA rejects Pfizer's Epogen biosimilar for anemia
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The FDA rejected Pfizer’s biologics license application for its proposed biosimilar to epoetin alfa for the treatment of anemia from various causes.
The rejection of epoetin Hospira (Pfizer) came just a month after the FDA’s Oncologic Drugs Advisory Committee voted 14-1 in favor of the biosimilar’s approval.
Pfizer had sought approval of epoetin Hospira — a biosimilar version of epoetin alfa (Amgen) — for the following indications:
- anemia due to chronic kidney disease, among patients on and not on dialysis, to decrease the need for red blood cell transfusions;
- anemia due to zidovudine administered at less than 4,200 mg/week for patients with HIV who have endogenous serum erythropoietin levels less than 500 milliunits/mL;
- anemia in patients with nonmyeloid malignancies who develop anemia from concomitant myelosuppressive chemotherapy; and
- to reduce the need for allogeneic red blood cell transfusions for patients with perioperative hemoglobin levels between 10 g/dL and 13 g/dL who are at high risk for perioperative blood loss from noncardiac, nonvascular surgery.
In its complete response letter to Pfizer, the FDA voiced concerns related to a previous warning letter issued in February about manufacturing violations at the company’s plant in McPherson, Kansas. The facility is listed as a potential production plant for epoetin Hospira.
Pfizer issued a statement noting the concerns expressed in the FDA’s warning letter did not relate specifically to the manufacture of epoetin Hospira.
In addition, FDA did not ask for additional clinical data to support approval.
“Pfizer submitted a corrective and preventative action plan to the FDA in March 2017, and has been diligently working to address the items outlined in the warning letter,” the company’s statement read. “Pfizer provides regular updates to FDA on the status of its action plan, and remains dedicated to addressing all of FDA’s concerns with the [site in McPherson, Kansas]. The company is committed to making this important treatment option available to patients and physicians as quickly as possible.”