Saturday, June 25 2022

Ongavia, a ranibizumab biosimilar developed by Teva Pharmaceuticals, has received UK regulatory approval for the treatment of several ophthalmic conditions, according to a statement from Teva.

The biosimilar referencing Lucentis has been approved by the UK Medicines & Healthcare Regulatory Agency for use in patients with vision loss resulting from neovascular age-related macular degeneration (wet AMD), macular edema diabetic disease, proliferative diabetic retinopathy, macular edema secondary to retinal vein occlusion or choroidal neovascularization. The UK is the first European country to approve Ongavia.

“Teva is delighted to bring Lucentis’ first biosimilar in ophthalmology to clinicians and patients in the UK,” said Richard Daniell, executive vice president of Teva Europe Commercial, in a statement. “Our mission is to improve access to advanced treatments at affordable prices and we are creating a role for biosimilars. We believe that unlocking the value of biologics is the new frontier of medicine and reducing system costs worldwide is the key to expanding patient access. We are committed to providing high quality products and services to support the eye care community.”

Ranibizumab products work by inhibiting vascular endothelial growth factor, which can lead to excessive blood vessel formation in the retina. AMD is the leading cause of blindness in developed countries and is estimated to affect up to 77 million people in Europe by 2050, creating a significant global burden on healthcare systems and societies.

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

In the COLUMBUS-AMD Phase 3 multicenter, randomized, double-blind, parallel-group study, Ongavia was comparable to the reference product in terms of clinical efficacy as well as ocular and systemic safety in patients with AMD.

Other companies looking to market their own ranibizumab biosimilars include Formycon, Intas Pharma, Xbrane Biopharma and STADA Arzneimittel, Polpharma Biologics and Coherus Biosciences.

The ranibizumab biosimilar created by Samsung Bioepis in partnership with Biogen (Byoviz; ranibizumab-runa) was the first Lucentis biosimilar to be approved in the United States, European Union and Canada.

Ongavia was developed in collaboration with BioEq. Under this partnership, Teva will have exclusive marketing rights in the UK, EU and Canada. The biosimilar is under review within the European Commission and submission for Canadian approval is expected to be completed by the end of 2022.

Including Ongavia, Teva currently has 13 biosimilars in its pipeline, of which 3 are in phase 3 trials and 8 are in preclinical development. In addition to Ongavia, the company’s biosimilar adalimumab, referencing Humira, is undergoing regulatory review and is part of a collaboration with Alvotech for commercialization in the United States.

Teva also has a commercialization agreement with Celltrion Healthcare for Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin, and Truxima (rituximab-abbs), a biosimilar to Rituxan. Herzuma was launched in the United States in March 2020 and Truxima was launched in November 2019.

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