Retinal Disease Drug Receives Approval from European Commission
Last week the European Commission granted marketing authorisation to Polpharma Biologics, Formycon, and Bioeq in their joint development of Ranivisio. Also known as ranibizumab, Ranivisio is a biosimilar of Lucentis, which is already a treatment for several serious retinal diseases throughout the European Union (EU).
News of the approval came after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion in June 2022 to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.
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Ranivisio was developed by Bioeq in a joint venture with Polpharma Biologics and Formycon, and is a visual impairment treatment. Teva later joined the strategic partnership in mid-2021.
Ranivisio is an effective therapeutic option for neovascular age-related macular degeneration associated with diabetic macular odema and choroidal neovascularisation. It also treats proliferative diabetic retinopathy and visual impairment which occurs as a result of macular oedema secondary to retinal vein occlusion.
The retinal drug achieved EU approval after demonstrating efficacy, safety, pharmacokinetics, and immunogenicity in patients with age-related neovascular macular degeneration during a Phase III study. The randomised and double-masked study demonstrated notable similarities between Ranivisio and reference product Lucentis, trademarked by Genentech Inc.
CEO of Polpharma Biologics responded to the approval with the following statement: “We are immensely pleased with this recognition by the European regulatory authorities of biosimilar ranibizumab. The production of biosimilars is a process with high levels of scientific rigor and the approval of Ranivisio is the culmination of years of dedication by Polpharma Biologics, and our partners, to successfully engineer this medical advancement for those with severe retinal impairments.”
Ranivisio was developed by Bioeq in a joint venture with Polpharma Biologics and Formycon, and is a visual impairment treatment.
Stefan Glombitza, CEO of Formycon AG added: “Due to the demographic development more and more people in Europe are affected by age-related macular degeneration and other severe retinal diseases. This is very often accompanied by significant impairment of quality of life. We are therefore particularly pleased that FYB201/Ranivisio - that we have developed together with Polpharma Biologics and Bioeq - can contribute to the treatment options of ophthalmologists and best possible care for these patients.”
Whilst the treatment is already available in the UK under the trade name of Ongvia, commercial launches across Europe are set to occur over the coming year.
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