The ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen, received approval from Canada’s drug regulator, Health Canada, on 8 March 2022. This is the first ranibizumab biosimilar to receive approval in Canada.
Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab [1].
Byooviz (SB11) was approved for the treatment of neovascular (wet) age-related macular degeneration (AMD); visual impairment due to diabetic macular oedema (DME), macular edema secondary to retinal vein occlusion (RVO), choroidal neovascularization (CNV) secondary to pathologic myopia (PM) and CNV secondary to ocular conditions other than AMD or PM, including but not limited to angioid streaks, post-inflammatory retinochoroidopathy, central serous choriorentinopathy or idiopathic chorioretinopathy.
Health Canada’s approval was based on ‘totality of evidence’ including quality, non-clinical data and clinical data. In a randomized, double-masked, parallel group, multicentre phase III study, the efficacy, safety, pharmacokinetics, and immunogenicity of ranibizumab were compared to the reference product in patients with wet AMD and were found to be similar.
Byooviz was approved in the US on 17 September 2021 [2], in Europe on 18 August 2021 [3] and in the United Kingdom on 31 August 2021 [1].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 25]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 25]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 25]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
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Source: Biogen, Samsung Bioepis
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