On 18 September 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the granting of a marketing authorization for nine biosimilars, including seven denosumab, one golimumab, and one ustekinumab biosimilar medicines.
Denosumab biosimilars
The denosumab biosimilars given the recommendation were: Reddy Holding’s Akyra and Xbonzy, Intas’ Denosumab Intas, Alvotech/Stada’s Kefdensis and Zvogra, and Teva’s Ponlimsi and Degevma.
The originator products are Amgen’s Prolia (60 mg/mL injection) and Xgeva (120 mg/mL injection). Prolia is approved for the treatment of bone resorption and postmenopausal osteoporosis, and Xgeva is approved for the treatment of bone fractures and neoplasm metastasis.
Acvybra, Denosumab Intas, Kefdensis, and Ponlimsi, are approved for the treatment of osteoporosis and bone loss.
Degevma, Xbonzy, and Zvogra, are approved for the prevention of skeletal-related events in adults and treatment of adults and skeletally mature adolescents with giant cell tumour of bone.
Those that are biosimilars to Prolia and available in 60 mg/mL injection are: Acvybra, Denosumab Intas, Kefdensis, and Ponlimsi.
Those that are biosimilars to Xgeva and available in 120 mg/mL injection are: Degevma, Xbonzy, and Zvogra.
In July 2025, the EMA recommended approval for two denosumab biosimilars [1].
By the end of September 2025, the EMA had recommended marketing authorization for 21 denosumab biosimilars (10 referencing Xgeva and 11 referencing Prolia), while the FDA had approved only 14 denosumab biosimilars, 7 each referencing Xgeva and Prolia, four with interchangeable designation [2].
First golimumab biosimilar Gobivaz approved in Europe
The golimumab biosimilar that received a positive opinion was Alvotech/Advanz Pharma’s Gobivaz. This marks the first approval in Europe for a biosimilar of Janssen’s Simponi. This milestone comes as other companies, including Bio-Thera with its candidate BAT 2506, are also developing golimumab biosimilars [3].
Golimumab is a monoclonal antibody that targets the inflammatory molecule tumour necrosis factor-alpha (TNF-alpha). It can be used in the treatment of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis [3].
Gobivaz is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, and ulcerative colitis.
For Advanz Pharma, this is their second approved biosimilar, following the aflibercept biosimilar Mynzepli, which was approved in June 2025 [4].
Ustekinumab biosimilar Usgena
The ustekinumab biosimilar receiving positive opinion was Bio-Thera/Stada’s Usgena. This is a biosimilar to Janssen/Johnson & Johnson’s Stelara.
Usgena is approved for the treatment of Crohn’s disease, plaque psoriasis and paediatric plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
This is Stada’s second ustekinumab biosimilar approved in Europe, after Uzpruvo. Uzpruvo was itself the first ustekinumab biosimilar approved in Europe on 9 November 2023 [5].
This brings the total number of approved ustekinumab biosimilars in Europe to 13, from 10 different companies [6].
The two denosumab products from Alvotech/Stada, Kefdensis and Zvogra, will join several others in Stada’s European biosimilar portfolio. This portfolio includes: teriparatide for bone health; bevacizumab in oncology; epoetin zeta in nephrology and oncology; adalimumab, tocilizumab, and ustekinumab in immunology; and aflibercept and ranibizumab in ophthalmology.
Related articles
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Clinical study advances for Alvotech golimumab and Dr Reddy’s rituximab biosimilars
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for four biosimilars targeting three therapies [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 13]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-four-biosimilars-targeting-three-therapies
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves six denosumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 12]. Available from: www.gabionline.net/biosimilars/news/fda-approves-six-denosumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for Bio-Thera’s golimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 13]. Available from: www.gabionline.net/biosimilars/research/clinical-trials-begin-for-bio-thera-s-golimumab-copy-biological
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommend approval for aflibercept, ustekinumab, and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 13]. Available from: www.gabionline.net/biosimilars/news/ema-recommend-approval-for-aflibercept-ustekinumab-and-pegfilgrastim-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of first ustekinumab biosimilar Uzpruvo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 13]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-first-ustekinumab-biosimilar-uzpruvo
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 13]. Available from:
www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
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