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In the past few weeks, several biosimilar products have been granted marketing authorization in Europe and Japan, and additional products have been recommended for approval in Europe.
The European Commission Approves Henlius and Organon's Denosumab Biosimilars: On September 19, 2025, Shanghai Henlius Biotech and Organon announced that the European Commission has granted marketing authorization for BILDYOS (denosumab) injection 60 mg/mL and BILPREVDA (denosumab) injection 120 mg/1.7 mL,biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products. BILDYOS is indicated for treatment of osteoporosis in postmenopausal women and in men at increased risk for fracture, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. BILPREVDA is indicated for the prevention of skeletal related events in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
In 2022, Shanghai Henlius Biotech entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including BILDYOS and BILPREVDA. Shanghai Henlius Biotech's denosumab biosimilars were approved by the FDA on August 29, 2025.
CHMP Adopts Positive Opinion for Denosumab, Golimumab, and Ustekinumab Biosimilars: The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for nine biosimilar medicines during its September 2025 meeting:
- Alvotech/Reddy Holding GmbH's Acvybra (denosumab), Intas's Denosumab Intas (denosumab), Alvotech/STADA's Kefdensis (denosumab), and Teva GmbH's PONLIMSI (denosumab), for the treatment of osteoporosis and bone loss.
- Teva GmbH's Degevma (denosumab), Alvotech/Reddy Holding GmbH's Xbonzy (denosumab), and Alvotech/STADA's Zvogra (denosumab), for the prevention of skeletal-related events in adults and treatment of adults and skeletally-mature adolescents with giant cell tumour of bone.
- Alvotech/Advanz Pharma Limited's Gobivaz (golimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis.
- STADA's Usgena (ustekinumab), for the treatment of Crohn's disease, plaque psoriasis and paediatric plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
Alvotech Announces Marketing Approval in Japan of Denosumab, Golimumab, and Aflibercept Biosimilars: On September 19, 2025, Alvotech announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd., has received marketing approval for three new biosimilars from the Japanese Ministry of Health, Labor and Welfare. The biosimilars approved for the Japanese market are:
- AVT03, a biosimilar to RANMARK (denosumab), which is marketed in some other countries globally as XGEVA (denosumab);
- AVT05, a biosimilar to SIMPONI (golimumab); and
- AVT06, a biosimilar to EYLEA (aflibercept).
According to Alvotech, AVT05 is the first golimumab biosimilar to be approved for sale in major markets globally.
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