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12 March 2015AmericasAndrew Williams

I won’t dance, so don’t ask me

On March 6, 2015, the US Food and Drug Administration (FDA) approved an application by Sandoz to market a biosimilar version of Amgen’s Neupogen(filgrastrim) biologic drug.  Neupogen is a 175 amino acid recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF), and is often prescribed for cancer patients on chemotherapy at times when they are at most risk of infection because their white blood cell count is low. Sandoz, a division of Novartis, will market its biosimilar under the brand name Zarxio.

This is the first such application to be approved using the new biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA). Much like with the Hatch-Waxman statute for small-molecule pharmaceuticals, the BPCIA includes both an abbreviated drug approval process and a mechanism by which the parties can address any patent claims while the drug is being approved.

Nevertheless, even though Sandoz chose to avail itself of the first part of the statute, thereby reducing the time and cost required to obtain approval of its drug, it chose not to supply Amgen with a copy of its biosimilar application. This thwarted Amgen’s ability to avail itself of the statutorily-mandated patent exchanges, nicknamed the biosimilar ‘patent dance’.

Because of this, it is unclear when Sandoz will actually be able to begin selling its new product, or if it launches  ‘at risk’, what will happen to the market if Amgen wins its patent battle. It is also unclear whether the BPCIA will be a viable mechanism to bring cheaper follow-on drugs to the market if applicants are able unilaterally to opt out of this delicately crafted system.

The case

With regard to the specifics of this case, Sandoz apparently informed Amgen on July 8, 2014 that it had filed a biosimilar filgrastrim application with the FDA. Around twenty days later, however, Sandoz informed Amgen that it would not provide “a copy of the application submitted to the FDA” or any “such other information that describes the process or processes used to manufacture the biological product that is subject of such application” as required by the BPCIA.

Without that information, Amgen claimed, it was unable to initiate the so-called patent dance. Instead, Amgen filed an action in the US District Court for the Northern District of California. Amgen asserted that the statute mandates the disclosure of the biosimilar application (“the ... applicant ... shall provide ...”), and that the statutorily-required 180-day “notice of commercial marketing” cannot occur before approval. As a result, Amgen sought an injunction to prevent Sandoz from marketing Zarxio.

In addition, likely prompted by the imminent approval of the Sandoz application, Amgen subsequently sought a preliminary injunction to prevent Sandoz from entering the market before these issues can be resolved by the court. In order to determine the appropriateness of a preliminary injunction, a court must weigh four factors:

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