TERIPARACCORD

What it is

TERIPARACCORD contains teriparatide (rbe) 250 micrograms/mL solution for injection. TERIPARACCORD is a biosimilar medicine to FORTEO solution for injection. Teriparatide (rbe) is produced in E. coli using recombinant DNA technology and is identical to the 34-N-terminal amino acid sequence of endogenous human parathyroid hormone.

Approved indications

— Treatment of osteoporosis in postmenopausal women and 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 TERIPARACCORD 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. Calcium and vitamin D supplements are advised in patients with a low dietary intake of these nutrients.

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, with effects observed at systemic exposures ranging from 3 to 60 times the exposure in humans given a 20 micrograms dose. No increased risk was identified in a study in which 30 monkeys were treated with teriparatide for 18 months and then observed for a further 3 years, and post marketing data in humans has not identified an increased risk. TERIPARACCORD should be prescribed to patients with a full explanation and their informed consent on the lifetime duration of 24 months treatment. Teriparatide has not been studied in patients with pre-existing hypercalcaemia, and patients with pre-existing hypercalcaemia should be excluded from treatment because of the possibility of exacerbating hypercalcaemia. In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection, with serum calcium concentrations reaching a maximum between 4 and 6 hours and returning to baseline by 16 to 24 hours after each dose. Teriparatide has not been studied in patients with active urolithiasis and should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition. In short-term clinical studies 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 when it occurred it happened within the first several doses and did not preclude continued treatment.

Contraindications

TERIPARACCORD should not be given to patients with hypersensitivity to teriparatide or to any of its excipients. TERIPARACCORD is contraindicated in pregnancy and breast-feeding, 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, and in patients with skeletal malignancies or bone metastases.

Regulatory history

TERIPARACCORD was approved by the TGA on 11 August 2025 following a comprehensive evaluation of its biosimilarity to Forteo. TERIPARACCORD was registered on the ARTG on 2 October 2025 (ARTG 407486) as a teriparatide 250 micrograms/mL solution for injection pre-filled pen.