An approval from the US Food and Drug Administration permitting Stada to supply the Retacrit (epoetin alfa-epbx) biosimilar version of Epogen/Procrit to partner Pfizer will allow the German firm to extend a long-standing European supply agreement for Retacrit to now also cover the potentially lucrative US market.
Launched in late 2018, Retacrit – which is still the only FDA-approved biosimilar rival to Epogen/Procrit (Also see "Pfizer’s Retacrit undercuts rivals" - Generics