FDA Approves Retacrit as a Biosimilar to Epogen/Procrit

It is approved for the treatment of anaemia due to effects of concomitant myelosuppressive chemotherapy

On 15 May 2018, the US Food and Drug Administration (FDA) approved Retacrit (epoetin alfa-epbx, Hospira Inc., a subsidiary of Pfizer Inc.) as a biosimilar to Epogen/Procrit (epoetin alfa, Amgen Inc.) for the treatment of anaemia due to chronic kidney disease in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

Healthcare professionals should review the prescribing information in the labelling for detailed information about the approved uses.

The approval was based on comparisons of extensive structural and functional product characterisation, animal data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity between Retacrit and US-licensed Epogen/Procrit demonstrating that Retacrit is highly similar to US-licensed Epogen/Procrit and that there are no clinically meaningful differences between the products. Retacrit has not been shown to be interchangeable with US-licensed Epogen/Procrit.

Like Epogen/Procrit, the labelling for Retacrit contains a Boxed Warning to alert healthcare professionals and patients about an increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumour progression or recurrence.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.