Biogen and Samsung Bioepis have launched Byooviz (ranibizumab-nuna) on the US market as the first ophthalmology biosimilar. It references Roche’s (Genentech’s) blockbuster therapy, Lucentis.
The ophthalmology biosimilar was approved in the US [1, 2] in September 2021 and had already been approved in Europe in August 2021 [3, 4]. In the US, Byooviz (ranibizumab-nuna) is approved for the treatment of neovascular age-related macular degeneration (nAMD), macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV) [2].
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 alpha (VEGF-A), a mechanism similar to bevacizumab [5, 6].
The list price will be US$1,130 per single use vial to administer 0.5 mg via intravitreal injection, 40% lower than the current list price of Lucentis.
The originator product Lucentis’ US patent expired in June 2020 and this first biosimilar of it will reach the market on 1 July 2022. In 2021, Lucentis generated global revenue of around US$3.4 billion), with just over 40% of sales in the US. It is hoped that the biosimilar’s launch will be key in increasing options and reducing the financial burden associated with current anti-VEGF treatments and thus increasing accessibility of treatment for patients suffering from retinal vascular disorders.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 17]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Phase III trial evidence used in approval of ranibizumab biosimilar Byooviz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 17]. Available from: www.gabionline.net/biosimilars/research/phase-iii-trial-evidence-used-in-approval-of-ranibizumab-biosimilar-byooviz
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 17]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of Samsung Bioepis Biogen’s ranibizumab biosimilar Byooviz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 17]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-samsung-bioepis-biogen-s-ranibizumab-biosimilar-byooviz
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 17]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
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