FDA has rejected Pfizer’s biosimilar for the second time
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Pfizer hits a major setback as the Food and Drug Administration (FDA) has rejected their biosimilar anemia drug. Surprisingly, Pfizer's biosimilar for Amgen's megahit Epogen got rejected for the second time since 2015 by the Food and Drug Administration.
On Thursday, Pfizer announced that they received a complete response letter (CRL) from Food and Drug Administration(FDA) for its proposed biosimilar.This drug has been on the market in Europe for years now. The CRL relates to the previous warning letter sent to the Pfizer about McPherson, Kansas plant.
This warning Letter issued on February 14, 2017 subsequent a routine Agency inspection of the company’s facility in McPherson, Kansas in 2016. Warning letter was regarding the manufacturing violations in the plant. The Pfizer had listed the facility as a possible production site for the biosimilar nominee on its Biologics License Application (BLA).
McPherson, Kansas plantwas bought as part of the $17 billion deal for Hospirain 2015, however there have been many warnings from the Food and Drug Administration that the manufacturing system it picked up were not up to scrape.
The pharma giant commented that the Food and Drug Administration did not ask for supplementary clinical data to affirm a further approval, which they had asked when the same drug was rejected in 2015.
FDA staff discovered the Pfizer product almost identical to the Amgen drugwhich hasgarnered nearly $1.3 billion last year for the Californian biotech. Following to that,an advisory committee review for the approval was 14-1 vote.
The rejection will be beneficial to Amgen, as its chartbuster drug will be safe from competition at least in the short-term. Epogen is utilized in treatment for the patients with lower than normal level of red blood cells induced by chronic kidney disease.