A new wave of lower cost drugs? FDA a step closer to approving first biosimilar in U.S.

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    (Elana Gordon/for WHYY)

    (Elana Gordon/for WHYY)

    It’s a move that some experts say could save the health system billions of dollars.

    And, it could soon be a reality.

    In a unanimous decision last week, a federal advisory committee recommended that the U.S. Food and Drug Administration approve the very first application for a biosimilar in the U.S.

    Many are calling it historic.

    That’s because while biosimilars have been in Europe for years, they’ve never been approved for sale in the U.S. They’re sort of like generics, except for more complex (and costly) biologic drugs that can’t exactly be replicated. They’re often injectible drugs, used in cancer treatments and they tend to require a provider to administer them.

    The Pulse was at the federal advisory meeting and brought back this audio report on what the decision could mean for patients, for the industry and for providers.

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