European Commission Approves Biosimilar Ranivisio for Treatment for All Five Lucentis Indications
30 August 2022 - - The European Commission has granted a Marketing Authorization for Ranivisio (ranibizumab), a biosimilar of the ophthalmology treatment Lucentis across all five indications in adults for which Lucentis is authorized, Israel-based Teva Pharmaceutical Industries Ltd said.

Ranivisio is licensed in adults to treat age-related macular degeneration and four other ophthalmology indications: visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment resulting from diabetic macular oedema, proliferative diabetic retinopathy, and choroidal neovascularisation.

Around 67 m people in Europe are affected by AMD. It is a leading cause of blindness for working age adults with uncontrolled diabetes, and the most common cause of blindness in developed countries.

It is estimated that up to 77m Europeans will be affected with AMD by 20504.

AMD is caused by excessive growth of blood vessels in the retina that leads to visual impairment and can even cause blindness.

Ranibizumab inhibits vascular endothelial growth factor, which is responsible for the excessive formation of these blood vessels in the retina.

In the COLUMBUS-AMD study, a randomized, double-masked, parallel group, multi-centre phase III study, ranibizumab was shown to be highly similar to its reference medicine in terms of clinical efficacy and ocular and systemic safety in the treatment of AMD and its other ophthalmology indications.

Teva Pharmaceutical Industries (NYSE: TEVA) (TASE: TEVA) has been developing and producing medicines for more than a century.

The company is in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area.

Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses and commercializes biosimilars. 

Formycon is a leading, independent developer of biopharmaceutical medicines, especially biosimilars.

The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval.

Polpharma Biologics is an international biotechnology company with integrated operations in the European Union, developing and manufacturing biosimilar medicines.

Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas.