FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar Posted 16/06/2017

US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Pfizer’s biosimilar version of Amgen/Johnson & Johnson’s Epogen/Eprex/Procrit (epoetin alfa).

Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

At their meeting on 25 May 2017, advisers from the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14−1 in favour of the recommendation to approve Pfizer’s epoetin alfa biosimilar (Epoetin Hospira) in all indications of the originator product (Epogen/Eprex/Procrit). Pfizer is seeking FDA approval of the following indications:

  • Treatment of anaemia due to:
    • Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis
    • Zidovudine in HIV-infected patients
    • The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
  • Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, non-cardiac, non-vascular surgery.

The committee concluded that ‘the totality of the evidence’ showed that Epoetin Hospira ‘is highly similar’ to Epogen/Procrit, ‘notwithstanding minor differences in clinically inactive components, and support a demonstration that there are no clinically meaningful differences between Epoetin Hospira and US-licensed Epogen/Procrit in terms of the safety, purity and potency of the product’.

Hospira’s epoetin alfa biosimilar (Retacrit) has been approved in Europe since December 2007 [1]. However, FDA rejected the company’s first attempt at US approval in October 2015 [2], just after Pfizer bought Hospira.

If approved, Epoetin Hospira will be Pfizer’s second biosimilar to be marketed in the US. Pfizer’s infliximab biosimilar Inflectra, was approved in November 2016.

Related article
Biosimilars of epoetin alfa

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. Hospira submits application to FDA for epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: www.gabionline.net/Biosimilars/News/Hospira-submits-application-to-FDA-for-epoetin-alfa-biosimilar

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Source: Pfizer, US FDA

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