Drug news
FDA issues Complete Response Letter for Retacrit biosimilar version of Epogen/Procrit- Hospira/Pfizer
Hospira (now a subsidiary of Pfizer) filed a 351(k) application at the FDA on 16 December 2014 for Retacrit (epoetin alfa biosimilar), a biosimilar version of Epogen/Procrit from Amgen and Johnson & Johnson with sales of $2 billion. The FDA has recently issued a Complete Response Letter requiring more data which Hospira expects to answer in early 2016 and therafter expects to have a review in six months. A lawsuit between Amgen and Hospira continues.
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