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A new drug that could save the US billions of dollars just got one step closer to approval

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Business Insider

A US Food and Drug Administration (FDA) advisory committee just gave a critical recommendation for a version of Remicade, a drug used to treat autoimmune diseases like Crohn's disease and rheumatoid arthritis.

The independent panel voted 21-3 in favor of the drug, which was developed by Celltrion and goes by the name Remsima.

The drug is called a "biosimilar," which is like a generic version of a biologic medication, a medicine produced by living cells.

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But it's a bit more complicated than that. Unlike generics for chemical-based drugs — think antibiotics or birth-control pills — that can be interchangeable with branded versions, the copycats of biologic medications, produced using living cells, have a few more caveats because the drugs might have different reactions in your body.

The panel's recommendation today suggests that there's enough data to show that the drug works pretty much exactly like its original version, Remicade. The FDA can take the panel's recommendation into consideration, but doesn't necessarily rule the same way. It is expected to either approve or reject the drug by April 6.
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Biosimilars like this one might be the best way to drive down the cost of biologic medications that have been around for a while. Last month, the IMS Institute for Healthcare Informatics estimated that biosimilars would have a $41 billion impact on the pharmaceutical industry over the next five years.

By other calculations, Dr. Steven Miller, the CMO of pharmacy-benefits manager Express Scripts, told Business Insider that the US could be saving $250 billion over the next 10 years. The discount of putting people on far less costly biosimilars — even just new patients who have never taken the original — will be substantial.

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