FDA approves STADA biologics facility to supply Retacrit for US patients

German generics major STADA Arzneimittel (SAZ: Xetra) today revealed that, following a six-day inspection, the US Food and Drug Administration (FDA) has approved the STADA-controlled entity as a manufacturing and storage site for Retacrit (epoetin alfa-epbx) drug substance, at the Norbitec biologics facility in Uetersen, Germany.

In 2018, Retacrit became the first available biosimilar to Procrit (epoetin alfa) and Epogen (epoetin alfa) from Amgen (Nasdaq: AMGN) and Johnson & Johnson’s (NYSE: JNJ) in the USA. It is an important therapy for anemia associated with chemotherapy and chronic kidney disease that has annual US sales in excess of $300 million.

Through FDA accreditation of the Norbitec biologics facility, STADA is now able to supply the Retacrit, one of the top-selling biosimilars in the USA, for Pfizer (NYSE: PFE) to market.