Abstract
The risk of osteoporosis increases significantly with age. This is associated with an increase in the risk of fractures as the most serious complication, which in elderly patients leads to a significant increase in mortality and morbidity and a significant reduction in quality of life.
Teriparatide is the first anabolic agent in the treatment of osteoporosis. Forsteo's entry into the market in 2003 marked the beginning of a new era in the treatment of osteoporosis.
Many studies have shown a positive effect of teriparatide when administered intermittently on the increase in bone density and the prevention of vertebral and non-vertebral fractures, but the economic cost of treating each patient represents a significant burden on the health system. The market entry of biosimilar teriparatide can significantly reduce these costs.
Biosimilar teriparatide RGB-10, based on extensive physicochemical and biological tests, demonstrated significant similarity of RGB-10 at a qualitative level, as well as the same pharmacokinetics and pharmacodynamics as the parent drug. Statistical analysis confirmed formal bioequivalence between the two preparations.
An equivalent effect on the increase in bone mineral density after 12 months of treatment has been demonstrated. Thanks to a similar increase in density in both preparations, a similar effect can be expected to reduce the risk of fractures.
The safety of treatment with both preparations, including their immunogenicity, is similar. Based on the high degree of similarity of preclinical data and the demonstration of complete bioequivalence, RGB-10 (Terrosa) was approved in 2017 by the European Medicines Agency for treatment in the same indications as teriparatide.