FDA ADVISORY COMMITTEE TO HOLD PUBLIC MEETING ON HOSPIRA’S PROPOSED EPOGEN/PROCRIT BIOSIMILAR

Amgen v. Hospira (epoetin alfa)  •  Biosimilar News

The FDA recently announced that the Oncologic Drugs Advisory Committee will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer (Hospira’s parent) announced earlier this year that it resubmitted the application in December 2016, following FDA’s rejection of the application in 2015.

According to the FDA announcement, Hospira’s biosimilar candidate has the following proposed indications: (1) treatment of anemia due to chronic kidney disease, including patients on dialysis and not on dialysis, to decrease the need for red blood cell transfusion; (2) treatment of anemia due to zidovudine administered at ≤4,200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of ≤500 m units/mL; (3) treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppresive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy; and (4) to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin >10 to ≤13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, and nonvascular surgery. These appear to be all the same indications as those approved for Epogen®/Procrit®.

FDA has opened docket FDA-2017-N-1063 for public comment on this meeting. Comments received on or before May 10, 2017 will be provided to the committee, whereas comments received after that date and by May 23, 2017 will be taken into consideration by the FDA.

 

 

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