US Supreme Court overturns ruling requiring 180-day delay in launch of biosimilars

The US Supreme Court on Monday in a 9-0 ruling overturned a lower court decision that had prevented Novartis from selling its biosimilar version of Amgen's Neupogen (filgrastim) until 180 days after gaining FDA approval. The court also determined that patent holders cannot compel companies developing biosimilars to provide information about their products. However, the court did suggest that drugmakers might be permitted to use state laws for the same goal. 

The appeal from Novartis, which the Supreme Court agreed to hear in January, centred on the drugmaker's disagreement regarding a provision in the 2010 Biologics Price Competition and Innovation Act. The legislation requires the makers of biosimilars to provide a six-month notice to patent holders regarding their intention to market a biosimilar. 

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In May 2015, a US appeals court granted Amgen's request for an injunction blocking Novartis from launching its Neupogen biosimilar Zarxio (filgrastim-sndz). Meanwhile, a court later rejected Amgen's arguments that it was not properly notified regarding Novartis' intention to launch Zarxio, with the court subsequently rebuffing Amgen's request for an injunction to delay the launch of the biosimilar. 

Zarxio was cleared by the FDA in March 2015 for the same indications for which Neupogen is marketed, marking the first approval of a biosimilar by the FDA. The therapy was launched in September 2015 at a 15-percent discount to Neupogen. 

For related analysis, read ViewPoints: Amgen loses biosimilar battle, but not the war.

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