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Byooviz
Published
Product name
Byooviz
Active ingredient
Ranibizumab
Submission type
New biosimilar medicine
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Byooviz (ranibizumab) was approved for the following therapeutic use:
Byooviz (ranibizumab) is indicated in adults for:
- the treatment of neovascular (wet) age-related macular degeneration (AMD),
- the treatment of visual impairment due to diabetic macular oedema (DME),
- treatment of proliferative diabetic retinopathy (PDR),
- the treatment of visual impairment due to choroidal neovascularisation (CNV),
- the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM),
- the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO).
How this medicine works
Byooviz (ranibizumab) is a biosimilar medicine to Lucentis (ranibizumab).
Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A (VEGF-A). It binds with high affinity to the VEGF-A isoforms (for example, VEGF110, VEGF121 and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2.
Binding of VEGF-A to its receptors leads to endothelial cell proliferation and neovascularisation, as well as vascular leakage, which are thought to contribute to the progression of the neovascular form of age-related macular degeneration, to the development of choroidal neovascularisation (CNV), including CNV secondary to pathologic myopia or to the macular oedema causing visual impairment in diabetes and retinal vein occlusion.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Byooviz was considered favourable for the therapeutic use approved.
Sponsor