On 16 September 2022, Partners Stada Arzneimittel and Xbrane Biopharma announced that the European Medicines Agency’S (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Ximluci, a biosimilar candidate referencing Lucentis (ranibizumab). In addition, on 19 September 2022 in the US, Coherus BioSciences announced that from 3 October 2022, another ranibizumab biosimilar, Cimerli (ranibizumab-eqrn) will be commercially available.
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].
Lucentis is the originator product developed by Roche (Genentech) and is a blockbuster drug with global revenue of around US$3.4 billion in 2021, with just over 40% of sales in the US [2]. The originator’s US patent expired in June 2020 and the European patent is expiring in 2022 [3].
Ximluci positive opinion in Europe
Ximluci has been recommended for approval in the European Union (EU) for the treatment of wet AMD, diabetic macular oedema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV). The positive opinion will now be referred to the European Commission (EC) and a decision will be made on whether to grant marketing approval.
Cimerli US launch
Cimerli (also known as Ranivisio, Ongavia, FYB201 and CHS-201) was developed by Swiss biotechnology company Bioeq, a joint venture between Poland-based Polpharma Biologics and Germany-based Formycon [4].
US-based Coherus acquired rights to commercialize Bioeq’s ranibizumab biosimilar in the US in 2019 [5].
Cimerli (ranibizumab-eqrn) is the first interchangeable ranibizumab biosimilar approved by the US Food and Drug Administration for the treatment of neovascular (wet) (nAMD) and other serious retinal diseases. This covers all five indications of the originator biological Lucentis and includes diabetic macular oedema, diabetic retinopathy, macular oedema following retinal vein occlusion and myopic choroidal neovascularization [4].
The product has also been approved in Europe under the name Ranivisio [6] and in the UK as Ongavia [7].
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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 Oct 28]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. Byooviz: first ophthalmology biosimilar launches in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 28]. Available from: www.gabionline.net/biosimilars/news/byooviz-first-ophthalmology-biosimilar-launches-in-us
3. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal).2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 28]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ranibizumab-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Teva signs deal with Bioeq for ranibizumab biosimilar FYB201 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 28]. Available from: www.gabionline.net/pharma-news/teva-signs-deal-with-bioeq-for-ranibizumab-biosimilar-fyb201
6. GaBI Online - Generics and Biosimilars Initiative. EC approves ranibizumab biosimilar Ranivisio [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 28]. Available from: www.gabionline.net/biosimilars/news/ec-approves-ranibizumab-biosimilar-ranivisio
7. GaBI Online - Generics and Biosimilars Initiative. Lucentis biosimilars approved in the UK and Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 28]. Available from: www.gabionline.net/biosimilars/news/lucentis-biosimilars-approved-in-the-uk-and-korea
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