The FDA has accepted the biologics license application (BLA) for HLX14, a denosumab biosimilar developed by Organon and Shanghai Henlius Biotech. This acceptance marks a significant step toward potentially increasing the availability of more affordable treatment options for osteoporosis and other bone-related conditions.
The BLA for HLX14 is supported by comprehensive data, including comparative quality analytical studies and clinical studies designed to demonstrate its similarity to the reference product, denosumab (Prolia/Xgeva). These studies include a two-part Phase 1 clinical study in healthy Chinese adult male participants and a randomized, double-blind, international multicenter, Phase 3 clinical study in postmenopausal women with osteoporosis at high risk for fracture.
Denosumab is approved for various indications, including treating postmenopausal women at high risk for fracture, patients with intolerance or inadequate response to other osteoporosis treatments, and patients who will be taking corticosteroids for at least 6 months and are at a high risk for fracture. It is also used to increase bone mass in men with osteoporosis at a high risk for fracture and men at a high risk for fracture treated with certain medications for prostate cancer.
Clinical Trial Data
The clinical development program for HLX14 included rigorous comparative studies. The Phase 1 study assessed pharmacokinetic parameters, while the Phase 3 study evaluated the efficacy, safety, tolerability, and immunogenicity of HLX14 compared to Prolia in postmenopausal women with osteoporosis. These studies are crucial for demonstrating biosimilarity and ensuring that HLX14 can provide comparable clinical benefits to the reference product.
Commercialization Agreement
Organon has exclusive commercialization rights to HLX14 in key markets, including the United States, the European Union, and Canada, but excluding China, under a license and supply agreement with Henlius established in 2022. This agreement positions Organon to potentially expand access to denosumab treatment options in these regions.
Current Market Landscape
In March 2024, the FDA approved the first denosumab biosimilars, denosumab-bddz, marketed as Wyost and Jubbonti. Wyost is approved to reduce the risk of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, as well as for treating giant cell tumor of bone and hypercalcemia of malignancy. Jubbonti is approved for treating postmenopausal women and men with osteoporosis, glucocorticoid-induced osteoporosis, and to increase bone mass in women undergoing adjuvant aromatase inhibitor therapy for breast cancer.
The potential approval of HLX14 could further enhance competition and access to denosumab biosimilars, offering cost-effective alternatives for patients requiring these treatments.
