FDA clears first ever 'biosimilar' drug, paves way for cheaper drugs

New drug Zarxio helps prevent infections in cancer patients undergoing chemo

New York

THE US Food and Drug Administration (FDA) has approved the first so-called biosimilar drug for use in the US, paving the way for less expensive alternatives to an entire class of complex and costly drugs.

The drug, called Zarxio, produced by Sandoz, helps prevent infections in cancer patients receiving chemotherapy. It is a close copy of an existing medication called Neupogen, made by Amgen.

It was approved in Europe in 2009 as Zarzio but has not been used in the US, in part because no regulatory pathway existed to bring biosimilars - approximate copies of drugs in a class known as biologics - to market.

But in January an expert panel unanimously recommended that the FDA approve it, and...

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