STADA and Xbrane Biopharma have announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Ximluci, a biosimilar referencing ophthalmology drug, Lucentis (ranibizumab). In addition, Samsung Bioepis and Samil Pharmaceuticals will launch their biosimilar of Lucentis, Amelivu, in South Korea.
Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. It inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A). Ranibizumab can be used to treat macular degeneration by inhibiting VEGF, which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The monoclonal antibody drug is indicated for the treatment of wet age-related macular degeneration (AMD), macular oedema, degenerative myopia and diabetes complications; all conditions of the eye causing vision loss [1].
Ximluci UK authorization
The European Commission granted marketing authorization Ximluci, a biosimilar referencing Lucentis ranibizumab, in 2022 [2]. Both this and the UK authorization are for Ximluci 10 mg/mL solution for injection and the product will launch in the regions in 2023.
Stada and Xbrane entered into an agreement in 2018 under which the two companies are jointly responsible for development and for manufacturing Ximluci. Stada now holds the marketing authorizations and the commercial rights to the biosimilar across all territories included in the agreement, which covers Europe, the US, several countries in the Middle East and North Africa region, and selected Asia-Pacific markets.
Amelivu launch in South Korea
Samsung Bioepis’ ophthalmology biosimilar was approved in the US in September 2021 [3, 4], Europe in August 2021 [5, 6], Canada [7] and South Korea [8]. In the US, it is marketed as Byooviz (ranibizumab-nuna) and is approved for the treatment of neovascular AMD (nAMD), macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV) [4]. However, delays to product launch in other regions occurred due to a patent-related agreement between Samsung Bioepis and Lucentis producer Genentech.
Now, Samsung Bioepis’ South Korean launch of biosimilar ranibizumab Amelivu, with partner Samil Pharmaceutical, has finally been announced following the expiration of Genentech’s Lucentis supplementary protection certificate [9].
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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 2023 Feb 24]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. Australia and EU: Alvotech Humira and Stada Lucentis biosimilars approved [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 24]. Available from:
www.gabionline.net/biosimilars/news/australia-and-eu-alvotech-humira-and-stada-lucentis-biosimilars-approved
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 24]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
4. 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 2023 Feb 24]. Available from:
www.gabionline.net/biosimilars/research/phase-III-trial-evidence-used-in-approval-of-ranibizumab-biosimilar-byooviz
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 24]. Available from:
www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
6. 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 2023 Feb 24]. Available from:
www.gabionline.net/biosimilars/news/ema-recommends-approval-of-samsung-bioepis-biogen-s-ranibizumab-biosimilar-byooviz
7. GaBI Online - Generics and Biosimilars Initiative. Canada approves ranibizumab biosimilar Byooviz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 24]. Available from:
www.gabionline.net/biosimilars/news/canada-approves-ranibizumab-biosimilar-byooviz
8. GaBI Online - Generics and Biosimilars Initiative. Lucentis biosimilars approved in the UK and Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 24]. Available from:
www.gabionline.net/biosimilars/news/lucentis-biosimilars-approved-in-the-uk-and-korea
9. GaBI Online - Generics and Biosimilars Initiative. New partnerships: Prestige-Intas and Samsung Bioepis-Samil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 24]. Available from:
www.gabionline.net/pharma-news/new-partnerships-prestige-intas-and-samsung-bioepis-samil
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