Conexxence (denosumab biosimilar) / Fresenius Kabi - LARVOL DELTA

Fresenius Receives FDA Approval for their Denosumab Biosimilars and Secures Global Settlement Agreement (Businesswire) - "Fresenius’ operating company Fresenius Kabi reached a global settlement with Amgen concerning their denosumab biosimilars, allowing launch in the U.S. in mid-2025 and in Europe later in H2 of 2025, subject to regulatory approvals....Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) of its operating company Fresenius Kabi, has been approved by the U.S. Food and Drug Administration (FDA)."

Biosimilar launch • FDA approval • Osteoporosis • Women's Health

A double-blind, randomized, two-arm, single-dose, parallel-group study in healthy participants to compare the pharmacokinetics, pharmacodynamics, and immunogenicity of FKS518 proposed biosimilar to denosumab with the originator (LUMIADE-1 study). (ASCO 2024) - "PK equivalence of FKS518 and denosumab originator product was demonstrated with similar PD, safety and immunogenicity profile for the two products. This study adds to the totality of evidence supporting FKS518 as a proposed biosimilar to denosumab."

Clinical • PK/PD data • Oncology • Solid Tumor

A randomized, double-blind, study to evaluate the efficacy, pharmacodynamics, safety and immunogenicity of FKS518 proposed biosimilar to denosumab with the originator in postmenopausal women with osteoporosis (LUMIADE-3 study). (ASCO 2024) - P3 | "We demonstrated the therapeutic equivalence of FKS518 and originator product. The safety data showed similar safety profiles for the FKS518 and the originator product groups. Results from this study add to the totality of evidence supporting the similarity of FKS518 as a proposed biosimilar to denosumab originator product, a RANKL inhibitor used in patients with bone metastases from solid tumors."

Clinical • PK/PD data • Hematological Malignancies • Multiple Myeloma • Oncology • Osteoporosis • Rheumatology • Solid Tumor

LUMIADE-3: A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=553 | Completed | Sponsor: Fresenius Kabi SwissBioSim GmbH | Active, not recruiting ➔ Completed

Trial completion • Osteoporosis • Rheumatology

LUMIADE-3: A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=553 | Active, not recruiting | Sponsor: Fresenius Kabi SwissBioSim GmbH | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2023 ➔ Jul 2023 | Trial primary completion date: Mar 2023 ➔ Jul 2023

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