Degevma (denosumab biosimilar) / Teva - LARVOL DELTA

The United States (U.S.) Food and Drug Administration (FDA) has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia… (Teva Press Release) - "The FDA approval of PONLIMSI was based on a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety, and immunogenicity profile as the reference product, Prolia...."

FDA approval • Osteoporosis

Teva receives European Commission approvals for PONLIMSI (denosumab) Biosimilar to Prolia and DEGEVMA (denosumab) Biosimilar to Xgeva (GlobeNewswire) - "Teva plans to launch both products in key European markets in the coming months."

EMA approval • Osteoporosis

Comparing Immunogenicity Between TVB-009 and Reference Denosumab in Healthy Adults and Participants with Postmenopausal Osteoporosis (ACR Convergence 2025) - P3 | "Immunogenicity profiles of TVB-009 and US-denosumab were similar in healthy participants and women with postmenopausal osteoporosis, with no detectable impact of ADA or neutralizing ADA on PK, PD, efficacy, and safety, further confirming that there are no clinically meaningful differences between TVB-009 and the reference denosumab."

Clinical • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Single Switch from Reference Denosumab to TVB-009 in Women with Postmenopausal Osteoporosis: Analysis of the Phase 3, Randomized, Double-Blind, Multinational, Multicenter Study (ACR Convergence 2025) - P3 | "Women with PMO who single-switched from reference US-denosumab to TVB-009 demonstrated a comparable safety, immunogenicity, and efficacy profile to those who remained on US-denosumab. Our results demonstrate that a single switch from reference denosumab to TVB-009 does not affect safety and efficacy in this population."

Clinical • P3 data • Back Pain • Gastroenterology • Immunology • Infectious Disease • Musculoskeletal Pain • Osteoporosis • Rheumatology

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025 (European Medicines Agency) - "On 18 September 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Degevma, intended for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone."

CHMP • Giant Cell Tumor of Bone