Terrosa (teriparatide biosimilar) / Daewon Pharma, Mochida, Gedeon Richter - LARVOL DELTA

Utilization of Best-Value Medicines for Teriparatide in the Irish Healthcare Setting (ISPOR-EU 2025) - "As of June 2025, there are five medicinal products containing teriparatide available on the national reimbursement list in Ireland; the reference medicine, Forsteo®, three biosimilar medicines, Movymia®, Sondelbay® and Terrosa®, and a hybrid medicinal product, Tetridar®. The implementation of BVMs as part of Health Technology Management (HTM) enhances the safe, effective and cost-effective use of medicines and products whilst also controlling utilisation and expenditure. Using this approach, a significant increase in the uptake rate of teriparatide BVMs has been achieved."

Real-world efficacy of a teriparatide biosimilar (RGB-10) compared with reference teriparatide on bone mineral density, trabecular bone score, and bone parameters assessed using quantitative ultrasound, 3D-SHAPER® and high-resolution peripheral computer tomography in postmenopausal women with osteoporosis and very high fracture risk. (PubMed, Osteoporos Int) - "The results of the analysis demonstrate the therapeutic equivalence of the teriparatide biosimilar (RGB-10) to reference teriparatide for the treatment of osteoporosis in postmenopausal women at very high risk of fracture."

Journal • Real-world • Real-world effectiveness • Real-world evidence • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

DANDYNAMIC BONE: Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease (clinicaltrials.gov) - P4 | N=66 | Recruiting | Sponsor: Ditte Hansen | Trial completion date: Feb 2025 ➔ Sep 2027 | Trial primary completion date: Feb 2024 ➔ Sep 2026

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Heart Failure • Nephrology • Orthopedics • Renal Disease • FGF23 • NF-κβ • TNFRSF11B • TRAP

Resolution of severe constipation following a switch from calcium carbonate to recombinant human PTH therapy: A case report (ESPE 2022) - "She developed constipation at 4-years-old when she was commenced on Movicol...Unfortunately, the patient developed soiling and management was escalated to Picolax and then Botox and manual extraction...She was admitted at 12 years of age for rhPTH (Terrosa) therapy subcutaneously...Recombinant human PTH therapy can be used successfully to wean calcium supplements and reduce severe complications secondary to the oral medication. It also improves compliance and overall bone biochemistry."

Clinical • CNS Disorders • Constipation • Endocrine Disorders • Epilepsy • Gastroenterology • Gastrointestinal Disorder • Hypoparathyroidism • Renal Disease

Comparative Physicochemical and Biological Characterisation of the Similar Biological Medicinal Product Teriparatide and Its Reference Medicinal Product. (PubMed, BioDrugs) - "The results of the quality comparability study demonstrated similarity of RGB-10 to the reference medicinal product, providing the scientific basis for conducting a specifically designed clinical programme, and supported registration of the Marketing Authorisation Application of RGB-10 in the EU."

Journal • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

A multicenter, randomized, rater-blinded, parallel-group, phase 3 study to compare the efficacy, safety, and immunogenicity of biosimilar RGB-10 and reference once-daily teriparatide in patients with osteoporosis. (PubMed, Osteoporos Int) - "The therapeutic equivalence of RGB-10 to reference teriparatide was demonstrated. RGB-10 had comparable safety profile to that of reference teriparatide."

Clinical • Journal • P3 data

"Analytical similarity assessment of teriparatide biosimilar Terrosa: Terrosa and Movymia both developed under the code name RGB10 were the first biosimilars of Eli Lillys osteoporosis biological ForteoForsteo teriparatide in Europe. Gedeon… https://t.co/4ifeJEQZOH #EliLilly" (@Lilly_bio)

Types of Thyatirinae (Lepidoptera: Drepanidae) in the collection of the Zoological Institute of the Russian Academy of Sciences. (PubMed, Zootaxa) - "caucasica Krulikowsky, 1901, is designated from the collection of Kiev University.                The following type localities are thereby fixed: Lagodekhi [Georgia] for Thyatira hedemanni Christoph, 1885, Pung Tung [Central Korea] for Thyatira moellendorfi Fixsen, 1887 and for Thyatira violacea Fixsen, 1887, Nikolaevsk-na-Amure [Far East of Russia] for Cymatophora or var. terrosa Graeser, 1888."

Journal

The first biosimilar approved for the treatment of osteoporosis: results of a comparative pharmacokinetic/pharmacodynamic study. (PubMed, Osteoporos Int) - "Based on the high level of similarity in the preclinical data and the results of this clinical study, marketing authorisation for RGB-10 (Terrosa®) was granted by the European Medicines Agency (EMA) in 2017."

Journal • PK/PD data

"Gedeon Richter Launches Terrosa (biosimilar, teriparatide) in Europe https://t.co/syIkM9QC9j" (@Pharmashot)

Biosimilar launch • Launch Europe