In March 2024, Formycon and MS Pharma announced that their FYB201/ranibizumab Ravegza, a biosimilar to Lucentis, has received marketing authorization from the Saudi Food & Drug Authority.
This news comes following the announcement earlier in the year, that Hungary-based specialty pharmaceutical company Gedeon Richter, has become a strategic investor in Formycon, via cash capital increase from authorized capital in the amount of 9.08% of Formycon’s share capital. This transaction opens up the possibility of jointly leveraging long-term strategic opportunities across development, manufacturing and commercial value streams.
Ranibizumab is a monoclonal antibody drug indicated for the treatment of various retinal conditions including 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 [2].
Ravegza (FYB201/ranibizumab) is approved in Saudi Arabia for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases including retinopathies secondary to diabetes.
Formycon’s ranibizumab product was developed by Bioeq AG, a joint venture between Formycon and Polpharma Biologics Group. This is already available in Europe, the US and UK under brand names, Ranivisio, Cimerli (ranibizumab-eqrn) and Ongavia, respectively [3-5].
In Saudi Arabia, Ravegza (FYB201) will be marketed by MS Pharma and the launch is planned in mid-2024. The product has already launched in Jordan in 2023 and is expected to launch in Algeria and other Gulf Cooperation Council (GCC) markets over the course of 2024.
Related article
Teva signs deal with Bioeq for ranibizumab biosimilar FYB201
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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 2024 May 7]. 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 2024 May 7]. Available from: www.gabionline.net/biosimilars/news/byooviz-first-ophthalmology-biosimilar-launches-in-us
3. GaBI Online - Generics and Biosimilars Initiative. EC approves ranibizumab biosimilar Ranivisio [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 7]. Available from: www.gabionline.net/biosimilars/news/ec-approves-ranibizumab-biosimilar-ranivisio
4. GaBI Online - Generics and Biosimilars Initiative. Progress for Lucentis (ranibizumab) biosimilars in Europe and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 7]. Available from: www.gabionline.net/biosimilars/news/progress-for-lucentis-ranibizumab-biosimilars-in-europe-and-the-us
5. GaBI Online - Generics and Biosimilars Initiative. Lucentis biosimilars approved in the UK and Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 7]. Available from:
www.gabionline.net/biosimilars/news/lucentis-biosimilars-approved-in-the-uk-and-korea
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