Sandoz Sends 351(k) BLA to FDA for First Denosumab Biosimilar

On February 6, Sandoz announced that the FDA has accepted its application for approval of a biosimilar to denosumab (reference brands, Prolia® and Xgeva®, from Amgen).

Sandoz opted not to seek a “skinny label.” The application seeks Prolia’s full set of osteoporosis indications as well as Xgeva’s oncology indications (postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that has spread to the bone, giant cell tumor of the bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy).

The phase 1/3 study supporting the 351(k) application tested GP2411 against Prolia in postmenopausal women with osteoporosis, finding it to be clinically equivalent in terms of pharmacokinetics, efficacy, safety, and immunogenicity. Denosumab is a RANKL monoclonal antibody.

Keren Haruvi, President of Sandoz and Head of North America, stated in its press release, “We are proud to be among the first to submit a BLA for a denosumab biosimilar as, if approved, it could increase patient access to an affordable, high-quality, potentially disease-modifying treatment across the US, while also delivering savings for healthcare systems.”

Combined 2022 revenues for Prolia and Xgeva were approximately $3.7 billion. Both products were launched in 2010; however, biosimilar launches may have to wait a bit. The main patent expiration for Prolia seems due to occur in February 2025, according to Amgen’s company filings.

Since we last reported on the progress in biosimilar development in this category in 2021, several manufacturers are also completing their phase 3 trials. Samsung Bioepis completed theirs in December 2022. Celltrion, Fresenius Kabi, and Shanghai Biomabs Pharma are scheduled to complete their own osteoporosis trials by mid-2023. At least two other manufacturers are working on denosumab biosimilars.

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