Osenvelt (denosumab-bmwo) / Celltrion - LARVOL DELTA

Celltrion gains Australian approval for three biosimilars in ophthalmology and bone disease (Chosun Biz) - "Celltrion announced on the 10th that it received item approval from the Therapeutic Goods Administration (TGA) of Australia for its ophthalmic treatment 'Eydenzelt' (ingredient name: Aflibercept) and the bone disease treatments 'Stoboclo' and 'Osenvelt' (Denosumab)....'Eydenzelt' is a biosimilar of Regeneron's Eylea and is approved for the treatment of myopic choroidal neovascularization....'Stoboclo' is a biosimilar of Amgen's Prolia and is approved for postmenopausal women with osteoporosis. Similarly, 'Osenvelt', a biosimilar of Amgen's Xgeva, received approval for preventing skeletal-related complications in patients with bone metastatic cancer and all other treatment indications held by the original drug in Australia."

Approval • Ophthalmology • Osteoporosis

Celltrion’s denosumab biosimilar lands in Korea at 28% discount to Prolia (Korea Biomedical Review) - "Daewoong Pharmaceutical said Wednesday it has launched Celltrion's Stoboclo (denosumab) in Korea, pricing the biosimilar at 111,384 won ($76.7), 28 percent below Amgen's Prolia, to treat osteoporosis."

Biosimilar launch • Pricing • Osteoporosis

Celltrion receives U.S. FDA approval for STOBOCLO (denosumab-bmwo) and OSENVELT (denosumab-bmwo) biosimilars referencing PROLIA and XGEVA (Celltrion Press Release) - "Celltrion...announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO (CT-P41, denosumab-bmwo) and OSENVELT (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA (denosumab) and XGEVA (denosumab) respectively for all indications of reference products...The FDA approval is based on robust clinical evidence, including results from Phase III clinical trials in postmenopausal women with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of CT-P41 to reference denosumab. Study results demonstrated that CT-P41 had equivalent efficacy and PD to reference denosumab with similar PK and comparable safety and immunogenicity profiles."

FDA approval • Osteoporosis

Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars (Businesswire) - "European Commission approval based on totality of evidence including extensive comparative analytical, pharmacokinetic and clinical data....The company expands its biosimilar portfolio to 11 in 2025 as planned, further strengthening its commitment to a portfolio of 22 drugs by 2030....Celltrion today announced that the European Commission (EC) has granted marketing authorization...products across two biosimilars...and Stoboclo and Osenvelt (CT-P41, denosumab), biosimilars referencing Prolia and Xgeva used for all indications of the reference products."

EMA approval • Osteoporosis

Impact of Immunogenicity on Clinical Outcomes in Postmenopausal Women with Osteoporosis: Results from a Randomized Controlled Phase 3 Study to Compare CT-P41 (Proposed Denosumab Biosimilar) and Reference Denosumab (ACR Convergence 2024) - "The result showed no discernible impact of ADA on PK, efficacy, and safety. Despite the high ADA incidence compared to the DEN historical studies, it can be concluded that ADA to CT-P41 and DEN has no clinical impact considering the high sensitivity and specificity of the assay and further evaluation of immunogenicity impact."

Clinical • Clinical data • P3 data • Osteoporosis • Rheumatology

Efficacy and Safety Results of CT-P41 (Proposed Denosumab Biosimilar) Compared to Reference Denosumab in Postmenopausal Women with Osteoporosis: 78-Week Results from Phase 3 Randomized Controlled Trial (ACR Convergence 2024) - "The comparable and sustained efficacy results up to Week 78 supported the therapeutic equivalence of CT-P41 and DEN in treating PMO. CT-P41 was also well tolerated with a safety profile comparable to that of DEN, and no notable safety issue was identified following the single transition from DEN to CT-P41 compared with CT-P41 and DEN maintenance groups up to Week 78."

Clinical • P3 data • Musculoskeletal Diseases • Oncology • Orthopedics • Osteoporosis • Rheumatology

Efficacy and Safety Results of CT-P41 (Proposed Denosumab Biosimilar) Compared to Reference Denosumab (Prolia) in Postmenopausal Women with Osteoporosis: 78-Week Results from Phase 3 Randomized Controlled Trial (ASBMR 2024) - No abstract available

Clinical • P3 data • Osteoporosis • Rheumatology

Efficacy and Safety Results of CT-P41 (Proposed Denosumab Biosimilar) Compared to Reference Denosumab (Prolia) in Postmenopausal Women with Osteoporosis: 78-Week Results from Phase 3 Randomized Controlled Trial (ASBMR 2024) - No abstract available

Clinical • P3 data • Osteoporosis • Rheumatology

Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. (PubMed, Osteoporos Int) - P3 | "CT-P41 was equivalent to US-denosumab in women with postmenopausal osteoporosis, with respect to primary efficacy and PD endpoints."

Journal • P3 data • Osteoporosis • Rheumatology

A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=479 | Completed | Sponsor: Celltrion | Active, not recruiting ➔ Completed

Trial completion • Osteoporosis • Rheumatology

A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males. (PubMed, Expert Opin Biol Ther) - P1 | "Following a single dose in healthy males, CT‑P41 demonstrated PK equivalence with US-denosumab. ClinicalTrials.gov: NCT06037395."

Clinical • Journal • P1 data • PK/PD data

Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=154 | Completed | Sponsor: Celltrion

New P1 trial

A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=479 | Active, not recruiting | Sponsor: Celltrion | Trial completion date: Mar 2023 ➔ Nov 2023 | Trial primary completion date: Sep 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Osteoporosis • Rheumatology

A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3; N=440; Active, not recruiting; Sponsor: Celltrion; Recruiting ➔ Active, not recruiting; Trial completion date: Aug 2023 ➔ Mar 2023; Trial primary completion date: Feb 2023 ➔ Sep 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Osteoporosis • Rheumatology

A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects (clinicaltrials.gov) - P1; N=30; Completed; Sponsor: Celltrion; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3; N=416; Recruiting; Sponsor: Celltrion; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Osteoporosis • Rheumatology

A Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3; N=416; Not yet recruiting; Sponsor: Celltrion

Clinical • New P3 trial • Osteoporosis • Rheumatology

A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Celltrion; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed