Teva Pharmaceitical (NYSE and TASE: TEVA) has announced that the UK Medicines & Healthcare Regulatory Agency (MHRA) is to grant a licence for “Ongavia”, a biosimilar to Lucentis (ranibizumab ). According to the company, the United Kingdom is the first country in Europe to authorize commercialization of Ongavia for the treatment of neovascular wet AMD”. In addition, the biosimilar is also licenced for the treatment of visual impairment due to diabetic macular oedema (DME); proliferative diabetic retinopathy (PDR); 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).
The MHRA approval is based on a totality of evidence including analytical, clinical and manufacturing data and in a randomized, double-masked, parallel group, mult-icenter phase III study, the efficacy, safety, pharmacokinetics and immunogenicity of FYB201/ONGAVIA was proven comparable to the reference drug Lucentis (ranibizumab) in patients with nAMD. In an earlier report, published in the journal Ophthalmology (vol. 129, no.1, Jan. 2022), a total of 477 patients were randomly assigned to receive FYB201/Ongavia (n = 238), or reference ranibizumab (n = 239), following which the BCVA improved in both groups, with a mean improvement of +5.1 (FYB201) and +5.6 (reference ranibizumab) ETDRS letters at week 8. According to the study, the analysis of covariance (ANCOVA) least squares mean difference for the change from baseline between FYB201 and reference ranibizumab was -0.4 ETDRS letters, with a 90% confidence interval (CI) of -1.6 to 0.9. The primary endpoint was met as the 90% CI was within the predefined equivalence margin and adverse events were comparable between treatment groups.
Teva has also entered into a strategic partnership for the exclusive commercialisation with Bioeq AG, a Swiss biopharmaceutical joint venture that develops, licenses and commercializes biosimilars across Europe. Following the announcement, Richard Daniell, Executive Vice President, Teva Europe Commercial, said: “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”.