Bosaya (denosumab-kyqq) / Biocon, Yoshindo - LARVOL DELTA

A randomized, double-blind, two-arm, single-dose, parallel study to compare the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of Bmab 1000 and originator denosumab in healthy male participants. (ASCO 2026) - "This study demonstrated PK bioequivalence and comparable PD, safety, and immunogenicity between Bmab 1000 and DENO in healthy male participants. Statistical results of the denosumab primary pharmacokinetics parameters."

Clinical • PK/PD data • Endocrine Disorders

Efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of Bmab 1000 vs reference denosumab: 78-wk results from a randomized, double-blind, multicenter, parallel-arm Phase 3 trial (DEVOTE) in women with postmenopausal osteoporosis. (PubMed, JBMR Plus) - P3 | "There was no effect of transitioning from reference denosumab to Bmab 1000. Clinical trial registration: EudraCT number: 2021-006545-36, CT.gov number: NCT05345691."

Clinical • Journal • P3 data • PK/PD data • Osteoporosis • Rheumatology

Biocon shares rise after Health Canada approves Bosaya and Vevzuo denosumab biosimilars for osteoporosis and cancer bone conditions, stock up about 1.5 percent at 364.40 (CNBC-TV18)

Canada approval • Commercial • Oncology • Osteoporosis

Biocon Ltd has announced the launch of two biosimilars, Bosaya and Aukelso, in the United States. (Devdiscourse) - "These medications, designed to treat serious bone conditions, are now available by prescription across the country."

Biosimilar launch • Giant Cell Tumor of Bone • Osteoporosis

Biocon Biologics Receives U.S. Food and Drug Administration Approval for Bosaya and Aukelso, Denosumab Biosimilars (Biocon Press Release) - "In addition, the U.S. FDA granted provisional interchangeability designation for both BOSAYA and AUKELSO....Clinical data showed that both biosimilars demonstrated comparable quality, safety, and efficacy to the reference product."

FDA approval • Giant Cell Tumor of Bone • Multiple Myeloma • Osteoporosis

Advancing Bone Health: European Commission Approves Biocon Biologics' Denosumab Biosimilars (PRNewswire.co.uk) - "Biocon Biologics Ltd ...announced that the European Commission (EC) has granted marketing authorisation in the European Union (EU) for Vevzuo and Evfraxy biosimilars of Denosumab. Vevzuo is authorised for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour (GCT) of bone. Evfraxy is authorised for the treatment of osteoporosis in men and postmenopausal women, the treatment of bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures or treatment of bone loss associated with long-term systemic glucocorticoid therapy in adults."

EMA approval • Giant Cell Tumor of Bone • Osteoporosis

Biocon Biologics receives MHRA UK approval (European Pharmaceutical Manufacturer) - "Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon, has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisations in the UK for Vevzuo and Evfraxy, biosimilars of Denosumab."

MHRA approval • Giant Cell Tumor of Bone • Osteoporosis

Biocon Biologics Receives Positive CHMP Opinions for Biosimilar Denosumab in Europe (Biocon Press Release) - "Biocon Biologics...today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions recommending the approval of its denosumab biosimilars candidates for distinct therapeutic indications for bone health: Vevzuo and Denosumab BBL (brand name is currently under approval)."

CHMP • Osteoporosis

A Randomized, Double-blind, Multicenter, Parallel-arm Phase 3 Study to Compare the Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab-1000 and Prolia in Postmenopausal Women with Osteoporosis (ACR Convergence 2024) - "This study demonstrated equivalent efficacy (%CfB in lumbar spine BMD) and PD (sCTX, AUEC) between Bmab-1000 and Prolia®, with similar safety and tolerability profiles."

Clinical • P3 data • PK/PD data • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

DEVOTE: Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=480 | Completed | Sponsor: Biocon Biologics UK Ltd | Active, not recruiting ➔ Completed

Trial completion • Osteoporosis • Rheumatology

Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS (clinicaltrials.gov) - P1 | N=190 | Completed | Sponsor: Biocon Biologics UK Ltd | Active, not recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ Oct 2023 | Trial primary completion date: Feb 2024 ➔ Oct 2023

Trial completion • Trial completion date • Trial primary completion date

DEVOTE: Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=480 | Active, not recruiting | Sponsor: Biocon Biologics UK Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Osteoporosis • Rheumatology

Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Male Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS (clinicaltrials.gov) - P1 | N=190 | Active, not recruiting | Sponsor: Biocon Biologics UK Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed

DEVOTE: Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=480 | Recruiting | Sponsor: Biocon Biologics UK Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Osteoporosis • Rheumatology