The FDA accredited Bosaya and Aukelso, biosimilars of Prolia and Xgeva, respectively, for the remedy of stable tumors, like breast and prostate most cancers.
The U.S. Meals and Drug Administration (FDA) has accredited Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), biosimilars of Prolia and Xgeva, respectively, for males at excessive danger of fracture present process androgen deprivation remedy for nonmetastatic prostate most cancers and to extend bone mass in ladies at excessive danger for fracture receiving adjuvant aromatase inhibitor remedy for breast most cancers, in keeping with a information launch from Biocon Biologics Ltd. (BBL).
Bosaya has been accredited as an injection for subcutaneous use in a single dose prefilled syringe, and Aukelso as an injection for subcutaneous use in a single-dose vial, respectively.
Biosimilars provide a lower-cost different to biologic medicines, used within the remedy of varied cancers. Though not an identical to the unique biologic, these biosimilars should meet rigorous FDA requirements to reveal that they’re equally efficient and protected because the reference brand-name merchandise, in keeping with the American Most cancers Society web site.
Shreehas Tambe, CEO & managing director of Biocon Biologics, highlighted the approval as a milestone in increasing affected person entry to essential biologic therapies. “With Bosaya, we offer a extra inexpensive possibility for osteoporosis, and with Aukelso, we broaden our oncology care portfolio,” Tambe mentioned. “This underscores our dedication to delivering high-quality biosimilars that enhance affected person outcomes and assist sustainable healthcare programs.”
The discharge additional notes that each therapies acquired provisional interchangeability designation, offering sufferers and healthcare suppliers higher flexibility in choosing these therapies.
Bosaya: Supporting Bone Well being Throughout Most cancers Remedy
Bosaya is accredited for a number of indications, together with the prevention of bone loss in males present process androgen deprivation remedy for nonmetastatic prostate most cancers and in ladies receiving adjuvant aromatase inhibitor remedy for breast most cancers. These therapies are generally utilized in most cancers care however can weaken bones, rising fracture danger. By focusing on Receptor Activator of Nuclear Issue Kappa-B Ligand (RANKL), the agent reduces bone resorption, serving to keep bone power and scale back fractures.
Scientific research present Bosaya matches the standard, security, and effectiveness of Prolia, the information launch continues. Nonetheless, sufferers with superior continual kidney illness, significantly these on dialysis, face the next danger of extreme hypocalcemia. Medical doctors will monitor calcium ranges intently and guarantee enough supplementation with calcium and vitamin D. Frequent uncomfortable side effects embrace again ache, joint ache, and fatigue, with critical however uncommon dangers akin to osteonecrosis of the jaw and atypical femoral fractures.
For sufferers with prostate or breast most cancers, sustaining bone well being throughout hormone-based therapies is essential. Bosaya affords a biosimilar possibility that may make remedy extra accessible whereas addressing this key side of most cancers care.
Aukelso: Addressing Bone Issues in Superior Most cancers
Aukelso is accredited to stop skeletal-related occasions in sufferers with bone metastases from stable tumors, together with breast and prostate cancers, and to deal with a number of myeloma, large cell tumor of bone, and hypercalcemia of malignancy. Bone metastases have an effect on greater than 330,000 sufferers within the U.S. yearly, inflicting ache, fractures, and diminished high quality of life. Aukelso works by focusing on RANKL, limiting bone breakdown and serving to shield skeletal well being in sufferers with superior most cancers.
Sufferers ought to pay attention to potential uncomfortable side effects, together with fatigue, nausea, low phosphate ranges, and hypocalcemia. Severe however much less widespread reactions embrace osteonecrosis of the jaw, atypical fractures, and a number of vertebral fractures following remedy discontinuation. Medical doctors will monitor calcium ranges intently and supply steering on supplementation to attenuate dangers.
By offering a biosimilar different, Aukelso might increase entry to efficient bone-targeted therapies for sufferers with breast and prostate cancers, providing an necessary device to handle cancer-related bone problems.
The Way forward for Bosaya and Aukelso
Each Bosaya and Aukelso symbolize an necessary development in most cancers and osteoporosis care. General, the information launch emphasizes that these biosimilars might present cost-effective choices with out compromising efficacy or security. For sufferers present process most cancers therapies that impression bone well being, these new choices provide the potential to scale back fracture danger and keep high quality of life, highlighting the evolving panorama of supportive care in oncology.
References
- “Biocon Biologics Receives U.S. Meals and Drug Administration Approval for Bosaya and Aukelso, Denosumab Biosimilars,” by Biocon Biologics Ltd. (BBL). Information launch; Sept. 17, 2025.
- “Biosimilar Medicines,” by American Most cancers Society. https://www.most cancers.org/most cancers/managing-cancer/treatment-types/biosimilar-drugs.html
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