DENOLIA

What it is

DENOLIA is a biosimilar medicine to Prolia, containing denosumab as the active ingredient. Each 1 mL single-use pre-filled syringe contains 60 mg denosumab. Denosumab is a human monoclonal IgG2 antibody with high affinity and specificity for RANK ligand (RANKL). DENOLIA is a sterile, preservative-free, clear, colourless to slightly yellowish or slightly brownish solution for injection at pH approximately 5.2.

Approved indications

— Treatment of osteoporosis in postmenopausal women, which significantly reduces the risk of vertebral, non-vertebral and hip fractures. — Treatment to increase bone mass in men with osteopaenia receiving androgen deprivation therapy for non-metastatic prostate cancer. — Treatment to increase bone mass in men with osteoporosis at increased risk of fracture. — Treatment to increase bone mass in women and men at increased risk of fracture due to long-term systemic glucocorticoid therapy.

Dosing overview

The recommended dose of DENOLIA is a single subcutaneous injection of 60 mg, once every 6 months. To reduce the risk of hypocalcaemia, patients must be adequately supplemented with calcium and vitamin D. In major clinical trials, daily supplementation with 1,000 mg of calcium and at least 400 IU vitamin D was recommended.

Key safety warnings

Hypocalcaemia must be corrected prior to initiating therapy with DENOLIA. In the post-marketing setting, severe symptomatic hypocalcaemia resulting in hospitalisation, life-threatening events and fatal cases has been reported, particularly in patients with severe renal impairment, receiving dialysis or treatment with other calcium lowering drugs. Clinical monitoring of calcium levels is recommended before each dose. Patients receiving DENOLIA may develop skin infections (predominantly cellulitis) leading to hospitalisation. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis. Osteonecrosis of the jaw has been reported in patients treated with denosumab or bisphosphonates. Most cases have been in cancer patients; however some have occurred in patients with osteoporosis. Osteonecrosis of the jaw has been reported rarely in clinical studies in patients receiving denosumab at a dose of 60 mg every 6 months for osteoporosis. It is important to evaluate patients for risk factors for osteonecrosis of the jaw before starting treatment. If risk factors are identified, a dental examination with appropriate preventive dentistry is recommended prior to treatment with DENOLIA. Atypical femoral fractures have been reported in patients receiving denosumab. Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur and may be bilateral. During DENOLIA treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Multiple vertebral fractures may occur following discontinuation of treatment with DENOLIA, particularly in patients with a history of vertebral fracture. New vertebral fractures occurred as early as 7 months after the last dose of denosumab. Patients being treated with DENOLIA should be advised not to interrupt therapy without prior consultation with their treating physician. If DENOLIA treatment is discontinued, consideration should be given to transitioning to an alternative antiresorptive therapy.

Contraindications

Hypocalcaemia is a contraindication. Hypersensitivity to the active substance, to CHO-derived proteins or to any of the excipients is a contraindication. DENOLIA is contraindicated in pregnancy and in women trying to get pregnant.

Regulatory history

DENOLIA was first listed on the ARTG on 31 October 2025 as ARTG 450306 (denosumab 60 mg/1 mL solution for injection prefilled syringe with automatic needle guard). An AusPAR was published on 26 March 2026.