## FDA Approves Two Denosumab Biosimilars: Boncresa and Oziltus
The FDA has approved two denosumab biosimilars, Boncresa and Oziltus (denosumab-mobz; Amneal Pharmaceuticals, mAbxience), for all indications of their respective reference products, Prolia and Xgeva (Amgen).1
“Biosimilars are the next wave of affordable medicines in the US, expanding access to life-changing biologics for millions of patients,” chirag and Chintu Patel, co-CEOs of Amneal Pharmaceuticals, said in a news release.1
Like its reference product, Prolia, Boncresa is indicated for the treatment of patients in several categories1:
* Postmenopausal women with osteoporosis who are at a high risk of fracture
* Men with osteoporosis who are at a high risk of fracture and need to increase bone mass;
* Men and women with glucocorticoid-induced osteoporosis who are at a high risk of fracture;
* Men receiving androgen deprivation therapy for nonmetastatic prostate cancer who are at a high risk of fracture and need to increase bone mass; and
* Women receiving adjuvant aromatase inhibitor therapy for breast cancer who are at a high risk of fracture and need to increase bone mass.
prolia has a boxed warning for severe hypocalcemia in patients with advanced chronic kidney disease, which can be life-threatening. Pregnancy must be ruled out prior to treatment. In postmenopausal women, reported adverse events (AEs) related to treatment included back pain, musculoskeletal pain, hypercholesterolemia, and cystitis. Back pain, joint pain…
*image credit: Pixel-Shot | stock.adobe.com*
Denosumab Biosimilars: A New Era in Bone Health Treatment
Table of Contents
On December 22, 2025, Amneal Pharmaceuticals announced a significant advancement in bone health treatment: the FDA approval of two denosumab biosimilars. These biosimilars reference Amgen’s Prolia® (denosumab-hlcl) and XGEVA® (denosumab-hlcl), opening the door for more affordable and accessible treatment options for osteoporosis, bone loss due to cancer, and other related conditions. This approval marks a crucial step in expanding patient access to vital therapies.
What is Denosumab and Why biosimilars Matter?
Denosumab is a human monoclonal antibody that works by inhibiting RANK Ligand (RANKL), a protein essential for the formation, function, and survival of osteoclasts – the cells that break down bone. Prolia® is primarily used to treat osteoporosis in postmenopausal women and men at high risk for fractures. XGEVA® is used to prevent skeletal-related events (like fractures,spinal cord compression,and bone pain) in patients with cancer that has spread to the bone.
Biosimilars are not generics. They are highly similar, but not identical, to the original biologic drug (in this case, denosumab). As of the complexity of biologic drugs,creating an exact copy is impractical. The FDA requires rigorous testing to demonstrate that a biosimilar is as safe and effective as the reference product. The introduction of biosimilars typically leads to increased competition, driving down costs and expanding patient access to these important medications.
Amneal’s Approved Biosimilars
Amneal received FDA approval for two distinct denosumab biosimilars:
- One referencing Prolia®: Designed for osteoporosis treatment and prevention.
- One referencing XGEVA®: Intended for preventing skeletal-related events in cancer patients.
Both biosimilars are available in the same strengths and dosage forms as their reference products, and will be administered via subcutaneous injection. The availability dates and specific pricing will be announced by Amneal in the coming months.
What Does This Mean for Patients?
The approval of these biosimilars offers several potential benefits for patients:
- Lower Costs: Biosimilars are generally less expensive than the original biologic drugs, making treatment more affordable.
- Increased Access: Greater competition can lead to a more reliable supply of medication.
- More Treatment Options: Patients and their healthcare providers will have more choices when selecting a treatment plan.
It’s important to note that patients currently taking Prolia® or XGEVA® should not switch medications without consulting their doctor. The decision to switch to a biosimilar should be made in collaboration with a healthcare professional,considering individual patient needs and circumstances.
Key Takeaways
- Amneal Pharmaceuticals received FDA approval for two denosumab biosimilars referencing Prolia® and XGEVA®.
- Biosimilars are highly similar, but not identical, to the original biologic drug and offer a cost-effective option.
- These approvals expand access to critically important treatments for osteoporosis and cancer-related bone complications.
- Patients should consult their doctor before switching from Prolia® or XGEVA® to a biosimilar.
looking Ahead
The approval of amneal’s denosumab biosimilars represents a significant milestone in the evolution of bone health treatment.We can anticipate further biosimilar approvals in the coming years, continuing to drive down healthcare costs and improve patient access to life-changing medications. The increased competition will also likely spur innovation in the field, leading to even more effective and convenient treatment options.
Publication Date: 2026/01/02 10:19:42
Source: Amneal Pharmaceuticals
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