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US Court blocks Novartis biosimilar Neupogen

Published on 08/05/15 at 01:15pm
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Novartis have been temporarily prevented from marketing its biosimilar version of Amgen’s drug Neupogen in the US.

Earlier this year Novartis earned a historic vote from the FDA when its generics arm Sandoz became the first pharma company to earn approval for Zarxio (filgrastim-sndz), for use to treat the same five conditions for which Amgen’s Neupogen (filagrastim) is licensed.

Zarxio is chemically and biologically indistinct from Neupogen, and was approved after Sandoz satisfied FDA regulators that Zarxio is ‘highly similar’ to the US-licensed Neupogen product.

But Amgen has gone to the courts to protect its product’s market share for as long as possible; Neupogen, which boosts white blood cells to help cancer patients fight off infection, generated around $1.2 billion in sales last year.

But Amgen’s first quarter financial report this year acknowledged that sales of Neupogen had decreased 15% year-on-year, from $289 million to $181m, “driven primarily by the impact of competition in the US”.

The US firm requested an injunction blocking Zarxio from the American market until a lower court ruling, which gave Novartis the green light to market its version, is resolved. Amgen has already lodged an appeal against the lower court decision.

The new order is expected to keep Zarxio off the US market until at least until 3 June, when oral arguments on the appeal are scheduled, though getting a final legal outcome could take longer.

There have been several legal twists in the battle between the Neupogen rivals. Amgen filed a federal lawsuit last year accusing Novartis of failing to disclose certain information about its product to Amgen, which Amgen said was required under US regulations. Amgen also alleged Zarxio would infringe upon a patent for Neupogen. Novartis denies the allegations.

Meanwhile in the EU Novartis’ lung cancer drug Zykadia (ceritinib) has been signed-off by the European Commission after being recommended by the EMA in March. Zykadia is the first treatment approved for patients in Europe with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have previously been treated with Pfizer’s ALK inhibitor Xalkori (crizotinib).

Bruno Strigini, president of Novartis oncology says: "The approval of Zykadia in the European Union is significant for ALK+ NSCLC patients who have exhausted the other treatment options for their disease. This approval is yet another example of our commitment to precision oncology and our continued focus on developing treatment approaches that target specific genetic and molecular characteristics of cancer."

Lilian Anekwe

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