UK First to Grant License for Teva’s Ophthalmology Biosimilar Ongavia For Wet AMD

UK First to Grant License for Teva’s Ophthalmology Biosimilar Ongavia For Wet AMD

May 20, 2022

Teva Pharmaceutical said it welcomes the UK Medicines & Healthcare Regulatory Agency (MHRA) decision to grant a licence for Ongavia, a biosimilar to Lucentis (ranibizumab). The United Kingdom is the first country in Europe to authorize commercialization of Ongavia for the treatment of wet age-related macular degeneration (AMD).

Ongavia is also licenced for the treatment of visual impairment due to diabetic macular edema (DME); the treatment of proliferative diabetic retinopathy (DR); the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO); and the treatment of visual impairment due to choroidal neovascularisation (CNV).

Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina2. Teva's biosimilar ranibizumab is highly similar to its reference medicine in terms of clinical efficacy, ocular and systemic safety in the treatment of patients with AMD and its other indications, as shown in the COLUMBUS-AMD study (a randomized, double-masked, parallel group, multi-centre phase III study).3

“Teva is pleased to bring the first biosimilar for Lucentis in ophthalmology to clinicians and patients in the UK. Our mission is to improve access to advanced treatments at attainable prices and we are establishing a role for biosimilars," Richard Daniell, Executive Vice President, Teva Europe Commercial, said in a company news release.

"We believe that unlocking value in biologics is the new frontier in medicine and lowering system costs around the globe is the key to broadening patient access. We are committed to high quality products and services to support the ophthalmology community,” he added.

Teva entered into a strategic partnership for the exclusive commercialization of ranibizumab with Bioeq AG. Teva hopes to commercialize the ranibizumab biosimilar across Europe.

* Lucentis is a registered trademark of Genentech Inc.

References:
1 Written by Editor. January 15, 2019 · Last reviewed January 7, 2022. Available at: https://www.diabetes.co.uk/diabetes-complications/diabetes-and-blindness.html
2 John Lowe et al., Experimental Eye Research 85 (2007) 425e430, Ranibizumab inhibits multiple forms of biologically active vascular endothelial growth factor in vitro and in vivo Available at: https://www.sciencedirect.com/science/article/abs/pii/S0014483507001534
3 Frank G HolzPiotr OleksyFederico RicciPeter K Kaiser, Joachim KieferSteffen Schmitz-ValckenbergCOLUMBUS-AMD Study Group - Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration, JAMA Ophthalmol. 2021 Jan 1;139(1):68-76. doi: 10.1001/jamaophthalmol.2020.5053 Available at: https://pubmed.ncbi.nlm.nih.gov/33957183/
4 Li JQ, Welchowski T, Schmid M, et al Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084 available at: https://bjo.bmj.com/content/104/8/1077