Comparison of Forteo and Teriparatide on Improvements in Bone Mineral Density

Abstract

PF708 teriparatide, manufactured by Alvogen, was approved through the 505(B)(2) application after the expiration of Forteo market exclusivity in October 2019. The 505(B)(2) application allows safety and efficacy information to come from studies not conducted by the applicant if it is demonstrated that the proposed product shares characteristics (active ingredient, dose, route of administration, strength) with the reference product and comparable pharmacokinetic data is established. Real-world data is thus needed to demonstrate equivalent safety and efficacy between Forteo and PF708 teriparatide. The purpose of this study was to evaluate changes in bone mineral density in osteoporotic patients treated with either Forteo or PF708 teriparatide for 18-24 months. This retrospective chart review included osteoporotic patients > 18 years of age who received PF708 teriparatide or Forteo prescriptions from the practice location and initiated therapy between October 1, 2019 and October 31, 2022. The primary endpoint was percent change from baseline in BMD of the lumbar spine, femoral neck, and total hip. A total of 108 patients were included: 27 (median age 67 years, 88.9% female) in the PF708 teriparatide group and 81 (median age 68 years, 85.2% female) in the Forteo group. There was no significant difference in median change from baseline BMD of lumbar spine (+9.6% vs +7.7%, P= 0.56), left femoral neck (1.5% vs 2.8%, P= 0.39), right femoral neck (+1.6% vs +4.4%, P= 0.14), left total hip (+2.4% vs +3.2%, P= 0.24), or right total hip (0.0% vs +1.4% , P= 0.71) with PF708 teriparatide vs Forteo, respectively. In this small retrospective study, effect on BMD and reported adverse events were similar between PF708 teriparatide and Forteo when used for the recommended duration of therapy.