SONDELBAY

What it is

SONDELBAY is a teriparatide 250 micrograms/mL solution for injection provided as a pre-filled pen. SONDELBAY is comparable to the reference product Forteo in terms of structure, physicochemical properties, biological activity, and nonclinical aspects.

Approved indications

— Treatment of osteoporosis in postmenopausal women. — Treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures. — Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

Dosing overview

The recommended dose of SONDELBAY is 20 micrograms administered once daily by subcutaneous injection in the thigh or abdomen. Treatment with teriparatide is recommended for a lifetime duration of 24 months treatment.

Key safety warnings

In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumour) that was dependent on dose and treatment duration, observed at systemic exposures ranging from 3 to 60 times the exposure in humans given a 20 micrograms dose. However, post marketing data in humans has not identified an increased risk. SONDELBAY should be prescribed to patients with a full explanation and their informed consent on the lifetime duration of 24 months treatment. In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection, reaching a maximum between 4 and 6 hours and returning to baseline by 16 to 24 hours after each dose. In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension were observed, typically beginning within 4 hours of dosing and spontaneously resolving within a few minutes to a few hours, and relieved by placing subjects in a reclining position.

Contraindications

SONDELBAY should not be given to patients with hypersensitivity to teriparatide or to any of its excipients, in pregnancy and breast-feeding, with pre-existing hypercalcaemia, severe renal impairment, metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucocorticoid-induced osteoporosis, unexplained elevations of alkaline phosphatase, prior external beam or implant radiation therapy to the skeleton, or in patients with skeletal malignancies or bone metastases.

PBS listing

Information on the PBS listing for SONDELBAY is not available in the provided source documents.

Regulatory history

SONDELBAY teriparatide 250 micrograms/mL solution for injection pre-filled pen was first listed on the ARTG on 2 October 2025. TGA approval was made on 11 August 2025, following a comprehensive evaluation of its biosimilarity to Forteo. PBAC recommended the medicine in September 2021 for osteoporosis treatment, with a clarification of PBS-subsidised treatment for patients who previously self-funded.