WASHINGTON – Federal health experts have unanimously endorsed a Novartis drug that is expected to become the first lower-cost copy of a biotech drug to reach the U.S. market.
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A panel of Food and Drug Administration experts says the company's version of Neupogen is highly similar to Amgen's original blockbuster biotech drug, which is used to boost blood cells that help cancer patients fight infections. The non-binding recommendation could pave the way for a new market of quasi-generic biotech medicines, capable of generating billions in cost savings for insurers, doctors and patients.
The FDA is slated to make its final decision on the drug in coming months.