Judge Rejects Amgen’s Effort to Block Sandoz Biosimilar Version of Neupogen

A federal judge denied Amgen Inc.’s effort to block the sale of Sandoz’s recently approved biosimilar version of Neupogen.

U.S. District Judge Richard Seeborg in San Francisco on Thursday rejected Amgen’s bid for a preliminary injunction blocking Novartis’ Sandoz from selling its Zarxio (filgrastim), a biosimilar version of Amgen’s Neupogen that was approved by the US Food and Drug Administration (FDA) on March 6.

In February, Thousand Oak-based Amgen filed paperwork seeking a preliminary injunction, arguing that Sandoz had not complied with the time elements specified in the law allowing bioismilars. Novartis’ attorneys filed counter arguments that Amgen’s lack of cooperation caused delays and timing issues. Amgen said that it intends to appeal Seeborg’s ruling.

Based on this case’s importance for future biosimilars, Amgen and Novartis agreed to jointly request expedited review of any appeal.

Sandoz’s Zarxio is the first biosimilar product approved in the U.S. It contains the same active ingredient as Amgen’s Neupogen, a blockbuster drug used to prevent infections in cancer patients. Neupogen generates $1.2 billion per year for Amgen. Biologics are derived from living cells and are produced through various process, such as recombinant DNA, controlled gene expression or antibody methods. Because of their complexity, biosimilars are considered similar but not copies of the drug.  Although Zarxio is not an exact duplicate of Neupogen, the drug has been approved for the same five conditions as Neupogen.

Biosimilars are expected to reduce costs of biologic drugs that are high in price. While biosimilars are not expected to reduce costs to the extent of generics, analysts expect biosimilar drugs to be priced at a 20 to 30 percent discount compared to the original, and those discounts may increase over time. By 2024, biosimilars are expected to reduce US drug spending by $40 billion.

 

Last updated: 3/20/15; 10:10am EST

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