UK Grants Licence for Teva's Ophthalmology Biosimilar Ongavia
17 May 2022 - - The UK Medicines and Healthcare Regulatory Agency decision to grant a licence for Ongavia, a biosimilar to Lucentis (ranibizumab), an eye injection, Israeli pharmaceutical company Teva Pharmaceutical Industries Ltd (NYSE: TEVA) said.

The United Kingdom is the first country in Europe to authorize commercialization of Ongavia for the treatment of neovascular age-related macular degeneration.

Ongavia is also licenced for: the treatment of visual impairment due to diabetic macular oedema; the treatment of proliferative diabetic retinopathy; 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.

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

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).

Teva entered into a strategic partnership for the exclusive commercialisation of ranibizumab with Bioeq AG.

Teva said it hopes to commercialise the ranibizumab biosimilar across Europe.

AMD is the most common cause of blindness in developed countries and it is estimated that up to 77m Europeans will be affected by 20504.

The consequences carry a significant global burden for healthcare systems and society.

With the incidence of wet AMD increasing, it is expected that a considerable amount of healthcare resources and careful planning will be needed for decades to come.

Teva 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 the Formycon Group. Bioeq develops, licenses and commercializes biosimilars.