The European Commission (EC) has granted marketing authorization (MA) to Polpharma Biologics, Formycon and Bioeq’s Ranivisio (Ranivisio – Ranibizumab), a biosimilar to Lucentis (ranibizumab-injection), for the treatment for several serious retinal diseases in the European Union (EU).
EC approval follows a positive opinion issued in June 2022 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein.
Ranivisio is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR), as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).
FYB201/Ranivisio was developed by Bioeq, a Joint Venture between Polpharma Biologics and Formycon. Mid 2021, Teva Pharmaceutical Industries Ltd. entered into a strategic partnership for the exclusive commercialization of FYB201 in Europe and selected other countries. Commercial launches across Europe are planned over the coming year, and the treatment is already available in the UK under the tradename Ongavia, following its approval by the Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
The EU-approval is based on the totality of evidence including analytical, nonclinical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS-AMD) it was shown that Ranivisio is highly similar to the reference product Lucentis in terms of comparable efficacy, safety, pharmacokinetics and immunogenicity in patients with age-related neovascular (wet) macular degeneration.
AMD is caused by excessive growth of blood vessels in the retina. Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels in the retina. In developed countries, AMD is the most common cause of severe visual impairment or blindness and it is estimated that up to 77 million Europeans will be affected by 2050. The consequences of AMD carry a significant burden for healthcare systems and societies as the increasing incidence of the condition is expected to absorb considerable amounts of healthcare resources and funds across the EU.
“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,” says Michael Soldan, CEO of Polpharma Biologics. “We look forward to working with our strategic partners to rapidly get this very important treatment to the people across Europe who need it most.”
“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,” says Dr. Stefan Glombitza, CEO of Formycon AG.
