Reviewers find Retacrit "highly similar" to reference products
In briefing documents released ahead of FDA's planned May 25 meeting of its Oncologic Drugs Advisory Committee, reviewers said the "totality of the evidence" suggests Retacrit epoetin alfa from Pfizer Inc. (NYSE:PFE) is "highly similar" to anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ). Reviewers said there were "no clinically meaningful differences" between the biosimilar and reference products.
An approval would be the first from FDA for a biosimilar of Epogen or Procrit. Pfizer is seeking Retacrit's approval in all of the reference products' indications, which include anemias associated with chronic kidney disease (CKD), chemotherapy and perioperative settings...