Canada Gives Samsung Bioepis A Further Ranibizumab Approval

Health Canada Nod For Byooviz Lucentis Rival Follows US And EU

Samsung Bioepis has racked up a further endorsement for its Byooviz biosimilar ranibizumab, after Health Canada approved the rival to Lucentis.

Canada flag eye
Samsung Bioepis has the first Canadian approval for the ophthalmic biosimilar • Source: Bo Valentino / Alamy Stock Photo

Samsung Bioepis has secured a further approval for its Byooviz (ranibizumab) biosimilar rival to Lucentis, from Health Canada. The approval follows previous nods in the US and EU as well as the UK last year for the groundbreaking ophthalmic biosimilar, previously known as SB11. (Also see "FDA Approves First Ophthalmic Biosimilar With Samsung Bioepis’ Lucentis Rival" - Generics Bulletin, 20 September, 2021.) 

In both the EU and US, the biosimilar is expected to launch in mid-2022. (Also see "Samsung Bioepis Scoops First EU Lucentis Biosimilar As 2022 Date Looms" - Generics Bulletin, 24 August, 2021

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