Pharma Focus Europe

European Commission Approves FYB201/Ranivisio® (Ranivisio - Ranibizumab), a Biosimilar to Lucentis®

Monday, August 29, 2022

Polpharma Biologics Group BV, Formycon AG, and Bioeq AG have announced that the European Commission (EC) has granted marketing authorization (MA) for Ranivisio® (Ranivisio - Ranibizumab), a biosimilar to Lucentis® (ranibizumab-injection), in the European Union (EU). This approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is valid in all EU member states, as well as Iceland, Norway, and Liechtenstein.

Ranivisio® is indicated for the treatment of several severe retinal diseases, including neovascular (wet) age-related macular degeneration (nAMD), visual impairment due to diabetic macular edema (DME) or choroidal neovascularization (CNV), proliferative diabetic retinopathy (PDR), and visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO).

The development of FYB201/Ranivisio® was a joint effort by Bioeq, a collaboration between Polpharma Biologics and Formycon. Teva Pharmaceutical Industries Ltd. has entered into a strategic partnership for the exclusive commercialization of FYB201 in Europe and selected countries. Commercial launches are planned across Europe in the coming year, and the treatment is already available in the UK under the tradename Ongavia® following approval by the Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.

The approval is based on a comprehensive evaluation of evidence, including analytical, nonclinical, clinical, and manufacturing data. In a phase III study (COLUMBUS-AMD), Ranivisio® demonstrated high similarity to Lucentis® in terms of efficacy, safety, pharmacokinetics, and immunogenicity for patients with age-related neovascular (wet) macular degeneration.

Age-related macular degeneration (AMD) is characterized by abnormal growth of blood vessels in the retina. Ranibizumab works by inhibiting vascular endothelial growth factor (VEGF), which is responsible for the excessive vessel formation. AMD is the leading cause of severe visual impairment or blindness in developed countries, and it is estimated that 77 million Europeans will be affected by 2050. The increasing prevalence of AMD poses a significant burden on healthcare systems, and the approval of Ranivisio® provides an important treatment option.

"We are delighted by the recognition of biosimilar ranibizumab by the European regulatory authorities. The approval of Ranivisio® is the culmination of years of dedicated work by Polpharma Biologics, our partners, and our commitment to scientific rigor. We are eager to collaborate with our strategic partners to promptly make this crucial treatment available to those who need it most in Europe," says Michael Soldan, CEO of Polpharma Biologics.

"Given the growing number of individuals affected by age-related macular degeneration and other severe retinal diseases in Europe, which often lead to significant impairment of quality of life, we are particularly pleased that FYB201/Ranivisio® - developed in collaboration with Polpharma Biologics and Bioeq - can contribute to the treatment options provided by ophthalmologists and offer the best possible care for these patients," says Dr. Stefan Glombitza, CEO of Formycon AG.

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