Amgen court hearing in patent lawsuit vs Sandoz over generic Prolia cancelled

Amgen court hearing in patent lawsuit vs Sandoz over generic Prolia cancelled

Amgen's lucrative bone drugs Prolia and Xgeva, both containing the active ingredient denosumab, have racked up impressive sales since their initial approvals in 2010. With Prolia generating over $4 billion and Xgeva bringing in $2.1 billion in 2021, it's no surprise that generic competitors are eager to enter the market [1]. However, ongoing patent litigation between Amgen and Sandoz, the manufacturer of the first approved denosumab biosimilars, is casting uncertainty on the launch timing [1].

Sandoz has obtained U.S. approvals for its biosimilars, Jubbonti and Wyost, which reference Amgen's Prolia and Xgeva, respectively [1]. These drugs treat all indications of the reference products and are interchangeable, enabling them to be substituted for the branded versions without approval from the prescriber [1]. However, legal disputes over Amgen-owned patents have hindered Sandoz from commenting on the anticipated launch timing or plans [1].

Amgen accused Sandoz of patent infringement in December 2021, claiming that the company's biosimilar candidate violates over 20 Prolia and Xgeva patents [2]. The biotechnology giant further argued that Sandoz failed to provide necessary details about its biosimilar's manufacturing process as required by law [2]. Amgen also expressed concern that an FDA approval decision could come before its relevant patents expire, potentially leading to significant financial losses [2].

The last denosumab patent is set to expire in July 2037 [1][2], providing a glimmer of hope for generic entrants. However, the ongoing legal battle between Amgen and Sandoz continues to complicate matters, leaving the future of the generic market for Prolia and Xgeva uncertain.

References:
[1] FiercePharma. (2022, February 9). Sandoz puts heat on Amgen as FDA approves first biosimilars for its bone blockbusters Prolia and Xgeva. Retrieved February 22, 2023, from https://www.fiercepharma.com/pharma/sandoz-puts-heat-amgen-fda-approval-first-biosimilars-its-bone-blockbusters-prolia-and-xgeva
[2] FiercePharma. (2022, February 11). Amgen sues Novartis' Sandoz over 21 alleged patent infringements on bone meds Prolia and Xgeva. Retrieved February 22, 2023, from https://www.fiercepharma.com/pharma/amgen-sues-novartis-sandoz-over-21-alleged-patent-infringements-bone-meds-prolia-and-xgeva