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First US biosimilar edges towards market

Nature Biotechnology volume 33, pages 222–223 (2015)Cite this article

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A Correction to this article was published on 12 May 2015

This article has been updated

If so, it would mark a very long-awaited victory for biosimilars developers. The FDA's biosimilar pathway was created in 2012 under the Biologics Price Competition and Innovation Act (BPCIA) after years of wrangling with originator firms. Zarxio's launch would be symbolic of FDA's broader blessing—at least in principle—for a whole new generation of cost-effective products. Zarxio, if approved to treat chemotherapy-induced neutropenia and related conditions, could save $5.7 billion in drug costs over the next decade, estimates US pharmacy benefit manager Express Scripts. No wonder New York–based Pfizer on February 5 deepened its commitment to biosimilars (and other hard-to-make generics) by a $17-billion bid for Lake Forest, Illinois–based Hospira, which is involved with two of the four known biosimilar submissions to FDA.

But if approval appears likely for Zarxio, several other barriers to commercial success remain (Nat. Biotechnol. 31, 264, 2013). Indeed, given the already relatively onerous nature of the US biosimilar pathway—known as 351(k)—“if this product doesn't successfully launch, the biosimilar pathway is killed,” according to one Washington, DC–based expert who wants to remain anonymous.

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  • 28 April 2015

    In the version of this article initially published, the caption stated that Amgen's Neupogen was the first biosimilar to be approved by the FDA, rather than saying that the first biosimilar for Neupogen had been approved by the FDA. The error has been corrected in the HTML and PDF versions of the article.

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    Melanie Senior

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Senior, M. First US biosimilar edges towards market. Nat Biotechnol 33, 222–223 (2015). https://doi.org/10.1038/nbt0315-222

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