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Terrosa

Published
Product name
Terrosa
Active ingredient
Teriparatide
Submission type
New biosimilar medicine
Decision
Approved
Decision date
Registration date
What this medicine was approved for

Terrosa (teriparatide) was approved for the following therapeutic use:

Terrosa is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures.

Terrosa is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture

How this medicine works

Terrosa (teriparatide) solution for injection is a biosimilar medicine to Forteo solution for injection. Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Teriparatide is the active fragment (1 to 34) of endogenous human parathyroid hormone, manufactured using recombinant DNA technology. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and teriparatide are mediated through binding to specific PTH cell surface receptors. Teriparatide binds to these receptors with similar affinity as PTH and has the same actions in bone and kidney as PTH. Like endogenous PTH, teriparatide is not expected to accumulate in bone or other tissues.

Why the TGA approved or did not approve this medicine

The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Terrosa was considered favourable for the therapeutic use approved.

Additional information

ARTG details: 326885

Sponsor
Gedeon Richter Australia Pty Ltd
ARTG details
N/A
Product types