Denub (denosumab biosimilar) / Alkem Labs, Theramex - LARVOL DELTA

Positive recommendations on new biosimilar medicines (European Medicines Agency) - "On 13 November 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 Osqay, intended for the treatment of osteoporosis in women who have been through menopause and men who are at increased risk of fractures, treatment of bone loss linked to hormone ablation in men with prostate cancer who are at increased risk of fractures or treatment of bone loss in adults associated with long-term treatment with systemic glucocorticoid."

CHMP • Osteoporosis • Prostate Cancer

A Prospective, Active-controlled, Randomized, Double-blind, Multicenter, Phase III Study to Compare the Safety and Efficacy of Biosimilar Denosumab vs Reference Denosumab in the Treatment of Postmenopausal Osteoporosis. (PubMed, J Assoc Physicians India) - "Biosimilar denosumab was comparable to reference denosumab with respect to its efficacy, safety, pharmacokinetics (PK), pharmacodynamics, and immunogenicity in women with postmenopausal osteoporosis. Thus, biosimilar denosumab is expected to improve the quality of life in osteoporotic patients at affordable prices."

Clinical • Journal • P3 data • Osteoporosis • Rheumatology

Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers (clinicaltrials.gov) - P1 | N=207 | Recruiting | Sponsor: Enzene Biosciences Ltd. | Trial completion date: May 2023 ➔ May 2024 | Trial primary completion date: May 2023 ➔ May 2024

Trial completion date • Trial primary completion date

Denosumab Reduces Type II Diabetes Risk (RheumNow) - "The British Medical Journal has publish a matched cohort analysis demonstrating that adults receiving denosumab had a lower risk of incident type 2 diabetes (NIDDM) compared with those taking oral bisphosphonates for osteoporosis....A 5 years, large population based study, showed higher RANKL levels were associated with a fourfold increased risk of type 2 diabetes."

Online posting

A Phase 3 Study to Compare Biosimilar Denosumab With Prolia® (clinicaltrials.gov) - P3 | N=504 | Recruiting | Sponsor: Enzene Biosciences Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Osteoporosis • Rheumatology

A Phase 3 Study to Compare Biosimilar Denosumab With Prolia® (clinicaltrials.gov) - P3 | N=504 | Not yet recruiting | Sponsor: Enzene Biosciences Ltd.

New P3 trial • Osteoporosis • Rheumatology