FDA Approves New Denosumab Biosimilars to Enhance Bone Health Treatment

The Food and Drug Administration (FDA) has granted approval to Shanghai Henlius Biotech and Organon for two denosumab biosimilars: Bildyos (denosumab-nxxp) injection 60 mg/ml and Bilprevda (denosumab-nxxp) injection 120 mg/1.7 ml. These biosimilars are designed to serve as alternatives to Amgen's Prolia and Xgeva, respectively, and are approved for all indications associated with the reference products.

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Jon Martin, U.S. commercial lead for biosimilars and general medicines at Organon, emphasized that these approvals represent a significant advancement in expanding access to essential bone care treatments, particularly for the aging population in the United States. He stated, “Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women.” The approvals are expected to enhance treatment options for millions of patients requiring bone health therapies.

FDA approves Henlius and Organon’s Prolia, Xgeva biosimilars

The FDA's decision was based on a comprehensive data package that demonstrated no clinically meaningful differences in safety, purity, and potency between the biosimilars and their reference products. This included structural and functional analytical data, clinical pharmacokinetic data, and comparative studies.

FDA Approves 2 Additional Denosumab Biosimilars in Prior Indications

Bildyos is indicated for treating postmenopausal women with osteoporosis at high risk for fracture, increasing bone mass in men with osteoporosis at high risk for fracture, and treating glucocorticoid-induced osteoporosis in both men and women. Bilprevda is approved for preventing skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, among other indications.

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Both biosimilars carry potential risks. For instance, patients with advanced kidney disease treated with Bildyos may face a higher risk of severe hypocalcemia. Common adverse reactions reported include back pain, musculoskeletal pain, and hypertension. It is advised that calcium levels be monitored, particularly during the initial weeks of treatment.

FDA Approves 2 Additional Denosumab Biosimilars in Prior Indications

While the approvals are seen as a positive step towards improving access to bone health treatments, some critics argue that the introduction of biosimilars may not significantly lower drug prices or improve accessibility as intended. Concerns have been raised about the overall impact of biosimilars on the market, particularly regarding the competitive landscape for existing treatments.

FDA approves Henlius and Organon’s Prolia, Xgeva biosimilars

• “The FDA approvals of Bildyos and Bilpreva mark a significant step toward expanding access to critical bone care treatments needed by millions of people in the United States, including a growing aging population.” — Jon Martin, U.S. Commercial Lead, Biosimilars and General Medicines at Organon

FDA approves Henlius and Organon’s Prolia, Xgeva biosimilars

• “This 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.” — Jon Martin

FDA approves Henlius and Organon’s Prolia, Xgeva biosimilars

The FDA's approval of Bildyos and Bilprevda represents a notable development in the biosimilar landscape, particularly for bone health treatments. As these products enter the market, their impact on patient access and treatment affordability will be closely monitored, alongside ongoing discussions regarding their role in the broader pharmaceutical market.

FDA Approves 2 Additional Denosumab Biosimilars in Prior Indications