Following the receipt of two Complete Response Letters from the US Food and Drug Administration related to manufacturing issues, US pharma giant Pfizer's (NYSE: PFE) Retacrit was finally cleared for marketing.
Retacrit, a copy version of Amgen (Nasdaq: AMGN) and Johnson & Johnson’s (NYSE: JNJ) Epogen/Procrit (epoetin alfa) is the first biosimilar erythropoiesis stimulating agent (ESA) to become available in the USA. A new report from Spherix Global Insights views the prospects for Retacrit.
According to Dr Jay Wish, Professor of Clinical Medicine at Indiana University and a well-known anemia expert: "The availability of Retacrit in the US is an advance that can potentially offset costs for the healthcare system and patients. The clinical development program for Retacrit and the product's extensive post-marketing experience in the EU demonstrate a high-quality alternative to branded ESAs which have been unchallenged since the introduction of Amgen's Epogen in 1999."
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