Terrosa® osteoporosis biosimilar treatment launched in Europe

A new biosimilar drug to treat osteoporosis is now available across Europe after the patent for its reference product expired.

The biosimilar teriparatide, Terrosa®, has been launched in Europe. The drug is approved in adults for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture as well as for osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

The medication, produced by Gedeon Richter, has been introduced following the expiry of the patent for the reference product, Eli Lilly’s Forsteo®, this month. The European Commission (EC) approved the biosimilar in 2017, after the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP).

Teriparatide is biosimilar to the biologically active fragment of the human parathyroid hormone, replacing the natural hormone and stimulating bone formation. Teriparatide is used for the treatment of osteoporosis as it reduces the risk of bone fracture. The condition is more common in women after the menopause, but it can occur in both men and women as a side effect of glucocorticoid treatment.

“We are excited about the introduction of Terrosa®, our first own-developed biosimilar product in Europe, as it reflects our commitment to scientific programmes linked to complex medications such as biologicals. Biosimilars will increase choice and access for patients in the European countries, while providing potential cost savings to healthcare systems. We look forward to bringing more high quality and affordable biosimilar products to the market,” said Gábor Orbán, Chief Executive Officer of Richter.