The US Food and Drug Administration (FDA) announced its approval to Pfizer subsidiary Hospira yesterday, following an advisory committee’s recommendation in May last year for the erythropoiesis-stimulating agent (ESA).
Retacrit (epoetin alfa-epbx) – designed to reduce or avoid the need for red blood cell transfusions – has been approved for all indications, including for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use in HIV patients taking zidovudine.
Spokesperson Thomas Biegi told us Pfizer plans to launch Retacrit in the US this year, priced at a “significant discount” to the current wholesale acquisition cost of Epogen and Procrit.
Vifor Pharma will commercialise Retacrit in the US dialysis market.
The approval marks Pfizer’s third in the US biosimilar market, following the authorisation of Inflectra (infliximab) in 2016 and Ixifi (infliximab-qbtx) in December last year – both of which are biosimilar versions of J&J’s TNF-inhibiting monoclonal antibody (mAb) Remicade.
Last month, the FDA halted approval for Pfizer’s proposed biosimilar version of Roche’s cancer drug Herceptin (trastuzumab), which Biegi told us did not relate to safety or clinical data concerns.