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4 May 2023AmericasMuireann Bolger

Amgen sues generic drug maker over bone treatments

Lawsuit concerns multibillion-dollar bone-strengthening drugs | Alleged dearth of information provided to patent owner before biologics licence application was approved.

Biotechnology firm  Amgen has taken aim at a  Novartis subsidiary to prevent the introduction of generic versions of the blockbuster drugs,  Prolia and  Xgeva.

In the complaint filed at the  US District Court for the US District of New Jersey on May 1, Amgen claims that the biosimilars proposed by  Sandoz infringed 21 patents. Prolia is prescribed to treat patients with a high risk of bone fracture, for example people suffering from osteoporosis.

Meanwhile, Xgeva is used to prevent fractures or spinal cord compression in cancer patients whose disease has spread to the bone, as well as to treat certain types of tumours.

The  US Food and Drug Administration (FDA) approved both drugs in 2010.

The dispute arose when Sandoz submitted a  biologics licence application (BLA) to the FDA last year, which was later accepted in February 2023.

According to the complaint, Sandoz provided a copy of its BLA to Sandoz “prematurely” in December 2022 before it had been approved, but had then subsequently failed to provide Amgen with any other relevant information.

“Despite Amgen’s repeated requests for specific information…which Amgen needed to fully evaluate whether Sandoz would infringe certain patents, Sandoz refused—and continues to refuse—to produce such information,” says the complaint.

Amgen sold $3.6 billion worth of Prolia and $2 billion worth of Xgeva last year, according to a company financial report cited  by Reuters.

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29 September 2017   AbbVie has settled its patent dispute over Amgen’s proposed biosimilar for Humira (adalimumab), a drug used to treat multiple types of arthritis as well as psoriasis.
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3 March 2016   Amgen and Sandoz are set to go head to head in another patent case, this time centring on Amgen’s arthritis treatment drug Enbrel.