Conexxence (denosumab-bnht) / Fresenius Kabi - LARVOL DELTA

Savings and the Opportunity for Expanded Treatment Access with Advent Biosimilar Denosumab: A U.S. Perspective (ASTRO 2026) - "This study demonstrates the cost savings that could be realized with the use of a denosumab biosimilar. As the US healthcare system experiences increased demands to control spending, policies that encourage the uptake of available biosimilars could help to alleviate budget constraints."

Genito-urinary Cancer • Hematological Malignancies • Multiple Myeloma • Oncology • Prostate Cancer • Solid Tumor

THE COST-EFFECTIVENESS AND GLOBAL REIMBURSEMENT LANDSCAPE FOR DENOSUMAB IN ONCOLOGY (ISPOR 2026) - "Denosumab provides value for money through reductions in SRE-related costs, though affordability and access issues remain with the reference product. As reimbursement decisions are largely influenced by cost-effectiveness, use of denosumab biosimilars may provide much-needed savings and improved patient access."

Clinical • Cost effectiveness • HEOR • Reimbursement • US reimbursement • Giant Cell Tumor of Bone • Hematological Malignancies • Lung Cancer • Multiple Myeloma • Osteosarcoma • Solid Tumor

Sustained Efficacy, Safety and Immunogenicity Following Single Switch from Reference Product Denosumab to Fks518 Proposed Biosimilar in Postmenopausal Women with Osteoporosis (Results from the Pivotal Lumiade 3 Study) (CRA-AHPA 2026) - "This study demonstrated therapeutic equivalence between FKS518 and reference denosumab and showed sustained efficacy after transitioning to FKS518, with no impact on safety or immunogenicity."

Clinical • Infectious Disease • Osteoporosis • Respiratory Diseases • Rheumatology

Pharmacokinetics and pharmacodynamics of the denosumab biosimilar FKS518 and reference denosumab in healthy subjects: the Lumiade-1 study. (PubMed, JBMR Plus) - "No anti-drug antibodies were detected in either treatment group. These results demonstrate that FKS518 is equivalent to originator denosumab with respect to PK profile."

Journal • PK/PD data • Musculoskeletal Diseases • Orthopedics

Refined ADA testing strategy to overcome sRANKL interference in denosumab/FKS518 immunogenicity assessment. (PubMed, Bioanalysis) - "These findings underscore the importance of early interference assessment and mitigation. A multi-tiered strategy, encompassing screening, confirmatory, and specificity tiers, provided a robust solution applicable to programs facing similar challenges."

Journal • TNFRSF11B • TNFSF11

Development and validation of a method for quantitation of CTx-1 for the assessment of biosimilarity of FKS518, a denosumab biosimilar. (PubMed, Bioanalysis) - "A retrospective analysis indicated that applying more flexible ranges and/or omitting ESC-based criteria for run acceptance would not have substantially changed the CTx-1 results. While recognizing the value of ESCs for stability and trending analysis and the importance of rigorous biomarker method development and validation in the assessment of biosimilarity, this paper fosters the discussion whether run acceptance based on tight ESC acceptance limits is always necessary."

Journal • Osteoporosis • Rheumatology

LUMIADE 3: Therapeutic Equivalence of Denosumab Biosimilar FKS518 to Reference Product in Postmenopausal Osteoporosis. (PubMed, J Endocr Soc) - "Immunogenicity was infrequently observed and similar between the FKS518 and the reference denosumab groups. This study demonstrated therapeutic equivalence of, and comparable pharmacokinetics, safety, and immunogenicity profiles between FKS518 and reference denosumab, completing the clinical evidence to propose FKS518 as a biosimilar to denosumab."

Journal • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Fresenius (FRE.DE) announced the launch of its denosumab biosimilars, Conexxence and Bomyntra, in Europe. (Nasdaq)

Biosimilar launch • Osteoporosis

A Randomized, Controlled, multicenter Study to Evaluate the therapeutic equivalence between FKS518 Proposed Biosimilar to Denosumab and the Reference Denosumab in Postmenopausal Women with Osteoporosis (LUMIADE-3 Study) (ASBMR 2025) - P3 | No abstract available

Clinical • Osteoporosis • Rheumatology

Sustained Efficacy, Safety and Immunogenicity Following Single Switch from Reference Product Denosumab to FKS518 Biosimilar in Postmenopausal Women with Osteoporosis (results from the pivotal LUMIADE 3 study) (ASBMR 2025) - P3 | No abstract available

Clinical • Osteoporosis • Rheumatology

Fresenius Expands Biosimilars Portfolio With The Launch of Denosumab Biosimilars in the U.S. (Businesswire) - "Fresenius announced today that its operating company Fresenius Kabi, has introduced two new biosimilars - Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) - in the United States...Conexxence is available in a 60 mg/mL single-use prefilled syringe. Bomyntra is available in a 120 mg/1.7 mL vial and a 120 mg/1.7 mL single-use prefilled syringe."

Biosimilar launch • Osteoporosis

Sustained Efficacy, Safety and Immunogenicity Following Single Switch from Originator Denosumab to FKS518 Proposed Biosimilar in Postmenopausal Women with Osteoporosis (results from the pivotal LUMIADE 3 study) (EULAR 2025) - P3 | "The results of this study demonstrated therapeutic equivalence between FKS518 and the originator and showed sustained efficacy after transitioning from the originator to FKS518, with no impact on safety or immunogenicity."

Clinical • Infectious Disease • Osteoporosis • Respiratory Diseases • Rheumatology

Analysing the Economic Impact of Denosumab in the Treatment of Osteoporosis (EULAR 2025) - "Published literature indicated reference product denosumab is generally cost-effective despite its high cost, owing to offsets from reductions in fracture-related treatment costs or QALY gains. However, affordability issues remain in regions with lower WTP thresholds. Further studies should be conducted to examine and quantify the impact of biosimilars which may help to mitigate the unmet needs in this therapeutic area."

HEOR • Breast Cancer • Genito-urinary Cancer • Musculoskeletal Diseases • Oncology • Osteoporosis • Prostate Cancer • Rheumatology • Solid Tumor

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2025 (European Medicines Agency) - "On 22 May 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 Bomyntra, intended for the prevention of skeletal-related events in adults with advanced malignancies involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour of bone. The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH. Bomyntra will be available as a 120 mg solution for injection in vials and pre-filled syringes."

CHMP • Giant Cell Tumor of Bone

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