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Have the biosimilar floodgates been opened in the United States?

Nature Reviews Drug Discovery volume 14, pages 303–304 (2015)Cite this article

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It took 5 years from the effective date of the Biologics Price Competition and Innovation Act (BPCIA) — the legislation introduced to create a pathway for the approval of biosimilar products — for the US Food and Drug Administration (FDA) to approve the first biosimilar product. In March 2015, Sandoz gained approval for filgrastim-sndz (Zarxio), a biosimilar version of Amgen's filgrastim (Neupogen). Will a flood of other biosimilars follow?

There are three main hurdles a biosimilar product must clear to enter the US market — regulatory exclusivity periods, regulatory 'biosimilarity' requirements and patent exclusivity periods. The BPCIA provides regulatory exclusivity to reference products by preventing the FDA from approving a biosimilar application until at least 12 years after approval of the reference product. The BPCIA also requires clinical biosimilarity, which the FDA assesses on the basis of “data derived from analytical studies; animal studies; and a clinical study or clinical studies, including the assessment of immunogenicity and [pharmacokinetics] and [pharmacodynamics]”. However, even if a biosimilar product can clear these two BPCIA hurdles, it may face patent infringement litigation, either from the reference product sponsor or from a third party.

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Acknowledgements

The views expressed in this article are personal to the authors and do not necessarily reflect those of other members of Foley & Lardner LLP or its clients.

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Authors and Affiliations

  1. Chemical, Biotechnology and Pharmaceutical Practice at Foley & Lardner LLP, 3000 K Street N.W., Suite 600, Washington, DC 20007-5109, USA, and the Editor of Foley & Lardner LLP's PharmaPatentsBlog.com.,

    Courtenay C. Brinckerhoff

  2. Chemical, Biotechnology and Pharmaceutical Practice at Foley & Lardner LLP, 3000 K Street N.W., Suite 600, 20007-5109, Washington, DC, USA

    Kristel Schorr

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  1. Courtenay C. Brinckerhoff
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  2. Kristel Schorr
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Correspondence to Courtenay C. Brinckerhoff.

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Foley & Lardner LLP represents clients in the biologic and biosimilars space, including one or more companies mentioned in the article. The article is based entirely on publicly available information and does not reflect any confidential information.

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Brinckerhoff, C., Schorr, K. Have the biosimilar floodgates been opened in the United States?. Nat Rev Drug Discov 14, 303–304 (2015). https://doi.org/10.1038/nrd4622

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