Boan Biotech Submits a Biologics License Application for Two Denosumab Biosimilars in the U.S.

Boan Biotech announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its two biosimilars: BA6101 (denosumab injection 60 mg) and BA1102 (denosumab injection 120 mg). This submission marks a milestone in the company’s efforts to accelerate the global expansion of its core products.

Denosumab is a RANK ligand (RANKL) inhibitor. BA6101 and BA1102 are proposed biosimilars of the reference biologics Prolia^® and Xgeva^®, respectively. The BLA submitted by Boan Biotech seeks approval for all indications currently approved for the two reference drug products: BA6101 for the treatment of conditions related to osteoporosis,¹ and BA1102 for the treatment of conditions related to bone metastases from solid tumors, multiple myeloma, giant cell tumor of bone, and hypercalcemia of malignancy.²

BA6101 and BA1102 were developed by Boan Biotech under its global R&D strategy, following a rigorous, stepwise approach in accordance with regulatory guidelines for biosimilars in the U.S., the EU, the UK, Japan, and China. Comprehensive pharmaceutical, non-clinical, human pharmacokinetic, and clinical efficacy studies have confirmed that both of them are highly similar to their respective reference products, showing no clinically meaningful differences in safety, purity, and efficacy.

Having been used in clinical practice for over ten years, denosumab is demonstrated to be safe and effective, supported by extensive real-world evidence. It is recommended by multiple authoritative clinical guidelines both in China and in other countries. The two originator drugs remain a cornerstone in treating the diseases they are indicated for, and the market for them and their biosimilars are promising. Publicly available data shows that the combined global sales of Prolia and Xgeva in 2025 were approximately USD 6.498 billion, of which approximately USD 4.333 billion was generated in the U.S.

To accelerate the commercialization of BA6101 and BA1102 in the U.S., Boan Biotech entered into an exclusive agreement with a global pharmaceutical company headquartered in China in December 2025 for the nationwide promotion of both products. The partner brings extensive capabilities across R&D, quality assurance, regulatory affairs, and commercial operations, and is one of the leading suppliers of injectable therapeutics in the U.S.

Boan Biotech is also actively expanding the global footprint of its denosumab biosimilars outside the U.S. Both products are commercially available in China. The Marketing Authorization Applications for them are under review in the UK. Furthermore, BA6101 has been approved for marketing in Bolivia. The company will continue to register and commercialize the two products in the EU, Japan, and other high-potential markets.

To promote its two denosumab injections globally, Boan Biotech has established a robust network of partners across regions. In China, the company is partnering with Qingdao Conson Pharmaceutical Co., Ltd.(Qingdao Conson) to promote BA6101 in the Chinese Mainland. It is also partnering with Kexing Biopharm Co., Ltd.(Kexing Biopharm) to commercialize both of them in the Hong Kong and Macao SARs. Internationally, the company has partnered with Shanghai Pharmaceuticals Co., Ltd.(Shaphar) and Pharmacare to commercialize the two injections in some Southeast Asian countries and some Latin American countries respectively.  

Jiang Hua, Chairlady and Chief Executive Officer at Boan Biotech, said:“We expect BA6101 and BA1102 to be our first products commercially available in international markets and key growth drivers for our overseas business, which will lay the foundation for the global rollout of our future biologics. They are already launched in China and well-received by physicians and patients alike. We will continue to work with our global partners to improve our commercialization network and speed up their launch across key markets. We remain committed to improving patient outcomes by delivering high-quality, affordable biologics.”

1.Indications covered by the U.S. BLA for BA6101: treatment 1) of postmenopausal women with osteoporosis at high risk for fracture, 2) to increase bone mass in men with osteoporosis at high risk for fracture, 3) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, 4) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and 5) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
2.Indications covered by the U.S. BLA for BA1102: 1) prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, 2) treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and 3) treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.