Amgen wins injunction barring US market entry of Novartis' Neupogen biosimilar Zarxio

The US Court of Appeals for the Federal Circuit granted Amgen's request for an injunction blocking the launch of Novartis' Zarxio (filgrastim-sndz), which is a biosimilar version of Amgen's neutropaenia drug Neupogen (filgrastim). The order will remain in effect until the court resolves Amgen's pending appeal of a lower-court ruling that had permitted Zarxio's market entry. Oral arguments in the case are scheduled for June 3.

Zarxio was cleared by the FDA in March for the same five indications as Neupogen and marked the first approval of a biosimilar in the US. However, the company had agreed to postpone its launch of the drug, which is currently available in more than 60 countries under the name Zarzio, as part of ongoing patent litigation with Amgen. Last year, Amgen filed a lawsuit claiming Novartis had failed to comply with information disclosure provisions required under the Biologics Price Competition and Innovation Act and that Zarxio would infringe on a patent for Neupogen, which amassed $839 million in US revenue last year. Novartis has denied the allegations. For related analysis, see ViewPoints: Approval of the first US biosimilar – the key questions.

A spokesperson for Amgen stated that the company was pleased with the appellate decision, while a Novartis spokesman indicated that the drugmaker looks forward to a prompt resolution of the appeal and a launch of Zarxio "in the near future." Meanwhile, the Swiss drugmaker has yet to provide pricing information on the therapy. Insurers are hoping that biosimilar products will be priced 40 percent to 50 percent lower than the cost of original brands in the US.

For related analysis, see ViewPoints: Novartis lands first blow in biosimilar legal case and Physician View Poll Results: Non-proprietary naming may hinder uptake of Zarxio, say some oncologists, but drug labelling a win for first US biosimilar.

See also ViewPoints: FDA's finalised biosimilar guidance attracting at least as much attention for what they do not contain.

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