FDA Committee Recommends Approval of Neupogen Biosimilar


In a move that should lead to patients saving several hundred dollars in cancer care costs down the road, an FDA advisory committee has recommended that the FDA approve a biosimilar product for Neupogen.

Neupogen (filgrastim) is a recombinant human granulocyte colony-stimulating factor with a number of clinical uses, among them helping chemotherapy patients recover from neutropenia and avoid febrile neutropenia.

A biosimilar drug is to a biologic drug what a generic drug is to a brand-name drug. Because biologics are in fact biological agents, they can't be exactly reproduced the way a simple drug can. The answer is a biosimilar, which is a substance that exhibits no clinical difference than the biologic on which it is based.

Currently, there are no biosimilars approved for use in the United States. The biosimilar for filgrastim, made by Novartis and marketed elsewhere in the world as Zarzio, would be the first such biosimilar approved by the US FDA, provided the FDA follows the recommendation of its committee, which is usually does.

Assuming the FDA approves this biosimilar, it should result in patients paying less for this injection.

Source: Medscape

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