Injunction blocks first US biosimilar

A US federal circuit court has granted a request by Amgen to temporarily block sales of the first biosimilar product approved by the US Food and Drug Administration (FDA).

In March, the FDA approved Zarxio (filgrastim-sndz) from Sandoz – the generic pharmaceuticals division of Novartis. The product is a generic version of Amgen’s Neupogen. Amgen’s injunction means that the company cannot market, sell or import Zarxio into the US until the court resolves a technical dispute between the companies.

Sandoz says it has invested years of effort and tens of millions of dollars to have the first biosimilar in the US. Competitors’ products are expected this year, so even a brief injunction would jeopardise the first-to-market advantage that it has earned.