Amgen successfully blocks sale of Sandoz’s Zarxio biosimilar

The US Court of Appeals for the Federal Circuit has blocked US sales of Sandoz’s Zarxio, the biosimilar version of Amgen’s Neupogen (filgrastim), an injection used to prevent infection in patients undergoing chemotherapy.

The injunction will remain in place until the US District Court for the Northern District of California clarifies whether Sandoz violated the Biologics Price and Competition Act (BPCIA), the regulatory pathway for biosimilar drugs, by failing to inform Amgen of its application to market a Neupogen biosimilar.

The injunction became effective on the day of the judgment, Tuesday (May 5). The Federal Circuit has asked Sandoz to submit a report on the damages it will accrue during the injunction within seven days of the judgment.

In March, the US Food and Drug Administration (FDA) approved Sandoz’s biosimilar version of Neupogen for sale in the US, despite Amgen filing a petition requesting its application be denied as Sandoz did not engage in the BPCIA’s so-called “patent dance”.

As part of the patent dance, biosimilar makers must notify the reference biologic drug maker when they ask for FDA approval.

The BPCIA, signed into law in 2010, introduced the patent dance as a means of reducing litigation by letting parties discuss the patents involved in a biosimilar application in order to avoid infringement claims.

Amgen argued that Sandoz incorrectly interpreted the act by failing to inform the company that it had filed an application for FDA approval to market its Zarxio biosimilar in July 2014.Amgen asked that the district court enter an injunction against the sale of the Zarxio biosimilar in October last year. Last month, that request was refused.

A hearing of the case is set for June 3.

A spokesperson for Amgen told LSIPR: “We are pleased that the appellate court entered in an injunction prohibiting Sandoz from marketing, selling, offering for sale, or importing into the US its Zarxio biosimilar product until the court resolves the appeal on the merits.”

Sandoz did not respond to a request for comment.