Novartis‘s subsidiary Sandoz has been cleared to launch its biosimilar Zarxio (filgrastim) in September, after the US Court of Appeals for the Federal Circuit declined Amgen‘s claims.
Amgen’s Neupogen is a prescription medicine that is developed to reduce the chance of infection due to a low white blood cell count in people with certain types of cancer (non-myeloid) who receive anti-cancer medicines (chemotherapy) that can cause fever and a low blood cell count.
The case focused on a 2010 law established by the US Federal Government to allow drug companies to sell lower-priced biosimilars once their patents expire.
Amgen has alleged that Novartis failed to follow regulatory terms of the federal law authorising biosimilars.
In March this year, Sandoz received approval from the US Food and Drug Administration (FDA) for its Zarxio (filgrastim-sndz), which is highly similar to the US-licenced reference product Neupogen.
Sandoz said that the court found that provision of the biosimilar application to the originator company within 20 days of filing, which is ‘patent dance’ component of the US biosimilar approval pathway or BPCIA, is optional.
The court also noted that the required notice of commercial marketing can only be provided to the brand company following FDA product approval, which must be at least 180 days before commercial marketing.
Sandoz Biopharmaceuticals and Oncology Injectables global head Carol Lynch said: "We welcome the Federal Circuit’s finding that the BPCIA’s patent dance is optional.
"As we have argued all along, the decision of a biosimilar applicant not to provide its dossier as one step in the ‘patent dance’ entitles the brand under the BPCIA to commence patent infringement proceedings, which Amgen has done here."
"We look forward to launching Zarxio after 2 September as the first US biosimilar."
However, Amgen’s fight against the start of sales Zarxio will also depend on the court’s decision over claims that the biosimilar infringed its patent for use of filgrastim, which is Neupogen’s active ingredient.