• Safi Bello

Pfizer's Epogen biosim scores solid backing from FDA staff ahead of panel review

Fierce Pharma ------- After picking up Hospira and its biosimilar programs for $16 billion, Pfizer is nearing an FDA ruling on its version of Amgen’s blockbuster anemia medicine Epogen—and so far, it's looking good. Agency reviewers found the Pfizer product nearly identical to the Amgen drug, exactly what a biosimilar is supposed to be. In a review document posted by the agency ahead of an advisory committee meeting Thursday, FDA reviewers called the Pfizer candidate “highly similar” to Amgen’s Epogen and Johnson & Johnson's Procrit, the same drug marketed for different uses under a licensing deal with the California biotech. That similarity stands despite “minor differences in clinically inactive components,” the reviewers wrote. There are “no clinically meaningful differences” between the two products “in terms of the safety, purity, and potency,” the documents state. To learn more click on the picture below to read the article.


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