Amgen and Novartis tussle over biosimilar injunction
Novartis has begun its court battle with Amgen over its biosimilar of cancer drug Neupogen, which Amgen is trying to block from the market.
Zarxio became the first biosimilar product approved in the US when the FDA deemed it ‘highly similar’ to Amgen’s Neupogen (filgrastim) in March. But the good news for Novartis was short-lived, as in May Amgen requested an injunction blocking the product from sale.
A trial began yesterday, with Novartis’ generics arm Sandoz asking a US appeals court to lift the injunction. Amgen is accusing Sandoz of infringing its patent and failing to make appropriate disclosures to the company that it was planning to release Zarxio, which is required under US regulations.
At the trial on Wednesday, Sandoz said that it did provide notice both when applying for FDA approval and after it received the approval, but Amgen contended that the company ‘didn’t follow the rules’.
The judges in the trial acknowledged that the law was complex, but did not necessarily make it mandatory for manufacturers to disclose the makeup and process of creating their biosimilar drug. However, they implied that pharma firms should provide notice that a biosimilar is the works.
As the first case of its kind, the ruling will be important in deciding how such approvals work in the future. The court may opt for a middle ground option, where biosimilar manufacturers would provide six months’ notice to the original drug maker after receiving FDA approval.
Sandoz is hoping it will be allowed to market Zarxio by 2 September at the latest.
Neupogen, which boosts white blood cells to help cancer patients fight off infection, generated around $1.2 billion in sales for Amgen last year – but its figures have declining recently as it faces increasing competition in the US and patients move onto its successor Neulasta (pegfilgrastim).
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