As one BPCIA case came to a close in May[1], another got underway. On May 1, 2023, Amgen filed a complaint in the District of New Jersey, accusing Sandoz of infringing patents that relate to denosumab, the active ingredient in Amgen’s PROLIA and XGEVA. PROLIA is prescribed for a high risk of bone fracture in certain settings, for example, patients suffering from osteoporosis. XGEVA is prescribed to prevent skeletal-related events (e.g., fractures or spinal cord compression) in cancer patients whose cancer has spread to the bone, as well as to treat certain types of tumors.

Back in February, the FDA accepted Sandoz’s FDA application for a proposed denosumab biosimilar. Now, Amgen is seeking a declaratory judgment of infringement and an injunction prohibiting the production and sale of the proposed biosimilar.

Amgen v. Sandoz, 2:23-CV-02406 (D. N.J.), is one of three BPCIA cases we will continue to monitor and discuss. The other two cases are Regeneron v. Mylan, 1:22-CV-00061 (N.D. W. Va.) (Reference Product: EYLEA)[2] and Biogen v. Sandoz, 1:22-CV-1190 (D. Del.) (Reference Product: TYSABRI). Stay tuned to the Biosimilar Bulletin for updates on these cases and more.

[1] On May 22, 2023, in Janssen Biotech v. Amgen, 1:22-CV-1549 (D. Del.), a joint stipulation of dismissal was filed due to settlement. https://www.biosimilarsip.com/2023/05/24/janssen-and-amgen-settle-stelara-bpcia-case/

[2] The two-week trial scheduled in this case is currently proceeding in the Northern District of West Virginia. Updates to come.