A U.S. Food and Drug Administration advisory panel on Wednesday unanimously recommended the agency approve a “biosimilar” version of Amgen Inc.’s cancer drug Neupogen.
The FDA panel concluded that Zarzio, a drug sold by the generic drug division of Swiss pharmaceutical giant Novartis Group, is highly similar to the Thousand Oak’s biopharmaceutical company’s Neupogen.
The term biosimilar applies to alternative versions of drugs that are made by or derived from living organisms. Small changes in the manufacturing process can produce different results; hence the drugs are similar but not necessarily identical to the original.
Neupogen, which Amgen received FDA approval to sell in 1991, is given to patients with cancer to help their white blood cell count, which can be reduced by chemotherapy. It had global sales of $1.4 billion in 2013, accounting for 8 percent of Amgen’s overall sales, but the drug’s U.S. patent expired in December.
The FDA, which isn’t required to follow the advice of its advisory committees, though it frequently does, is slated to make its final decision on the drug in coming months.
Despite the prospect of additional competition, shares of Amgen rose $5.34, or 3 percent, on Wednesday to close at $158.24.
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