In September 2025, ANVISA, the Brazilian Health Regulatory Agency, issued favourable opinions recommending marketing authorization for four biosimilars, including two biosimilars of denosumab, one of trastuzumab, and one of aflibercept [1].
Denosumab biosimilars
The denosumab biosimilars that received approval were Denbonli and Wyost from Sandoz.
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 [2]
Denbonli and Wyost are approved for the treatment of osteoporosis and the prevention of skeletal-related events and bone loss in cancer patients [1].
Denbonli, referencing Prolia, is available as a 60 mg/mL injectable solution in a 1 mL pre-filled syringe with a ready-to-use safety device.
Wyost, referencing Prolia, is available as a 120 mg injectable solution in a 1.7 mL clear glass vial ready for administration.
By the end of September 2025, the European Medicines Agency had recommended marketing authorization for 21 denosumab biosimilars (10 referencing Xgeva and 11 referencing Prolia) [3], while the FDA had approved only 14 denosumab biosimilars, 7 each referencing Xgeva and Prolia, four with interchangeable designation [4].
Trastuzumab biosimilar Bisintex
The trastuzumab biosimilar that received regulatory approval was Bisintex. It is manufactured by Shanghai Henlius and will be marketed by Abbott Brazil.
Bisintex is indicated for the treatment of metastatic breast cancer, early-stage breast cancer, and advanced gastric cancer and was developed through comparability with the reference product Herceptin (trastuzumab) [1].
Bisintex is supplied in clear glass vials as a lyophilized powder, which is reconstituted for intravenous injection. It is available in 150 mg and 440 mg strengths.
Aflibercept biosimilar Pavblu
Pavblu was the aflibercept biosimilar from Amgen that received approval by ANVISA.
Pavblu is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV) [1].
Pavblu is available as a 40 mg/mL injectable solution for intravenous or intravitreal use in a clear glass vial containing 0.278 mL.
By the end of September 2025, Brazil’s ANVISA has approved a total of 67 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].
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References
1. Cestari de Oliveira SH, Wassermann GE. Follow-on biologicals/biosimilars approved in Brazil: September 2025 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(2):47-52. doi:10.5639/gabij.2025.1402.008
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Dec 5]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Dec 5]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Dec 5]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-US
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