Posted from: Tuesday, December 11, 2018 - 05:09 PM - Present

Retacrit, Biosimilar to Epogen and Procrit, Launched

November 9, 2018 – Drug manufacturer Pfizer has announced the launch of Retacrit® (epoetin alfa-epbx), the first FDA-approved biosimilar for Amgen’s Epogen® (epoetin alfa) and Johnson & Johnson’s Procrit® (epoetin alfa).

Approved May 15, 2018, Retacrit is indicated to treat anemia caused by zidovudine (in patients infected with HIV), chronic kidney disease, or myelosuppressive chemotherapy. It is also indicated to reduce the chance that patients undergoing elective, noncardiac, nonvascular surgery may need a red blood cell (RBC) transfusion.

A black box warning cautions that erythropoiesis-stimulating agents (ESAs) like Retacrit may increase the risk of death or serious adverse cardiovascular reactions and stroke in certain patients. It also advises that ESAs may reduce overall survival time or increase the risk of tumor progression or recurrence in patients with certain cancers. ESAs should not be used to treat patients for whom the anticipated result of myelosuppressive chemotherapy is a cure. For patients who receive an ESA to reduce the chance of a needed RBC transfusion, the black box warning indicates there may be an increased risk of deep venous thrombosis (DVT), and DVT prophylaxis is recommended.

Recommended dosing with Retacrit depends on the indication. It is available in single-dose vials containing 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, or 40,000 Units/mL. The wholesale acquisition cost (WAC) is $11.03 per 1000 units/mL, a price reduction of 33.5% compared to the WAC for Epogen, and 57.1% compared to Procrit.

Last Updated Monday, September 16, 2019 - 08:46 AM.