FDA approves 2 biosimilar drugs for cancer-related bone problems
New treatments work like Xgeva and Prolia, but likely will be cheaper
The U.S. Food and Drug Administration (FDA) has approved two new biosimilar drugs — versions of brand-name therapies that have no clinically meaningful differences compared with their reference products — for use in helping prevent bone problems in certain people with myeloma and other types of cancers.
The two newly approved drugs are Bilprevda (denosumab-nxxp), a biosimilar to Xgeva (denosumab), and Bildyos (denosumab-nxxp), a biosimilar to Prolia (denosumab). Both biosimilars will be sold by Organon, a U.S.-based company primarily focused on addressing health needs that disproportionately affect women.
“The FDA approvals of Bildyos and Bilprevda mark a significant step toward expanding access to critical bone care treatments needed by millions of people in the US, including a growing aging population,” Jon Martin, U.S. commercial lead, biosimilars and general medicines at Organon, said in a press release. “Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women.”
Biosimilars are therapies designed to work identically to name-brand biologic drugs. They are essentially analogous to generics for traditional medications, but because living cells are used to make biologic drugs, the nomenclature and regulatory rules are slightly different. Biosimilars are generally cheaper than their name-brand counterparts, and they can help drive medication prices down by introducing more competition into the pharmaceutical marketplace.
According to Martin, the FDA’s approval “underscores Organon’s unwavering commitment to making treatments more accessible while focusing on creating a more sustainable future for the care of bone health.”
Biosimilar drugs Bilprevda, Bildyos now approved for myeloma patients
Both of the biosimilars are now authorized for the same uses as the respective name-brand medicines.
This means that Bilprevda is approved to prevent bone problems in people with multiple myeloma or bone metastases from solid tumors, as well as to treat a type of bone cancer called giant cell tumor of bone. It’s also indicated for managing hypercalcemia of malignancy, a cancer complication marked by high calcium levels.
Bildyos, meanwhile, is approved to prevent bone problems in people receiving certain treatments for prostate or breast cancer, and also to treat certain forms of osteoporosis, a condition marked by abnormally weakened bones.
We are working to broaden access to important treatment options and better meet the needs of both patients and providers in the U.S..
Both of the newly approved biosimilar drugs work by blocking the activity of RANKL, a protein that helps regulate bone remodeling. Organon is marketing the two biosimilars as part of a 2022 agreement with their original developer Henlius Biotech. Under that agreement, Organon secured rights to commercialize these and other biosimilars in markets outside of China, where Henlius is based.
“These approvals are a testament to the strong collaboration between Henlius and Organon to expand patient access to quality and potentially more affordable biosimilars,” said Ping Cao, chief business development officer and senior vice president of Henlius. “Together, we are working to broaden access to important treatment options and better meet the needs of both patients and providers in the U.S.”
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