On 18 August 2021, the ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen, received European Commission (EC) approval. Then on 20 September 2021 the pair announced that Byooviz had also received approval from the US Food and Drug Administration (FDA). This is the first ranibizumab biosimilar, or indeed ophthalmology biosimilar, to receive approval in either Europe or the US.
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 .
The approval by the EC, on 18 August 2021, follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 25 June 2021 . The EC’s approval is based on the CHMP recommendation, which was based on a phase III clinical trial showing equivalent efficacy to the originator product. Improvements in primary efficacy outcomes remained stable and were equivalent between treatment groups at all time points.
The EC has approved Byooviz for the same indications as the originator product, blockbuster wet age-related macular degeneration (AMD) treatment Lucentis (ranibizumab), which is marketed by Genentech (Roche)/Novartis. These including wet AMD and diabetic macular oedema (DMO).
Samsung Bioepis submitted its proposed ranibizumab biosimilar (SB11) to FDA back in November 2020 . The agency approved Byooviz (ranibizumab-nuna), for the treatment of neovascular (wet) AMD, macular oedema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). The FDA’s approval of Byooviz was based on a review of evidence that included extensive structural and functional characterization, comparative clinical efficacy and safety evaluations, including potential immunogenicity (type of immune response) that demonstrated Byooviz is biosimilar to the originator product, Lucentis (ranibizumab).
Byooviz marks the seventh European approval for biosimilars from Samsung Bioepis. The company has also gain EC approval for Aybintio (bevacizumab), Benepali (etanercept), Flixabi (infliximab), Imraldi (adalimumab), Onbevzi (bevacizumab) and Ontruzant (trastuzumab) .
In the US, Samsung Bioepis has gained approval for four biosimilars. Renflexis (infliximab-abda) was approved in April 2017, Ontruzant (trastuzumab-dttb) in January 2019, Eticovo (etanercept-ykro) in April 2019 and Hadlima (adalimumab-bwwd) in July 2019 .
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Biosimilars applications under review by EMA – July 2021
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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
2. 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 2021 Sep 24]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-samsung-bioepis-biogen-s-ranibizumab-biosimilar-byooviz
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 24]. Available from: www.gabionline.net/biosimilars/news/FDA-accepts-application-for-ranibizumab-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 24]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 24]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
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Source: Biogen, EMA, Samsung Bioepis, US FDA
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