Teva’s Lucentis Biosimilar Gains UK Approval

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

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

“Teva is pleased to bring the first biosimilar for Lucentis in ophthalmology to clinicians and patients in the UK,” Richard Daniell, executive vice president at Teva Europe Commercial, said in a statement. "Our mission is to improve access to advanced treatments at attainable prices and we are establishing a role for biosimilars. 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."

Ranibizumab products function 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 impact up to 77 million people in Europe by 2050, creating a significant global burden for health care systems and societies.

“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 wrote.

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

Other companies who are looking to release 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 (Byooviz; ranibizumab-runa) was the first biosimilar to Lucentis to be approved in the United States, European Union, Canada. Byooviz was also approved in the United Kingdom in August 2021, making Ongavia the second ranibizumab biosimilar to be approved in the country.

Ongavia was developed in collaboration with BioEq. As part of the partnership, Teva will have exclusive commercialization rights in the United Kingdom, the European Union, and Canada. The biosimilar is under review within the European Commission and submission for Canadian approval is expected to be completed in late 2022.

Including Ongavia, Teva currently has 13 biosimilars in its pipeline, 3 of which are in phase 3 trials and 8 are in preclinical development. In addition to Ongavia, the company’s adalimumab biosimilar referencing Humira is under regulatory review and is a 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 launched in the United States in March 2020 and Truxima launched in November 2019.