Teva’s biosimilar Lucentis gets UK approval

Ongavia, per ranibizumab biosimilar developed through Teva Pharmaceuticals, contains received UK regulatory approval for certain treatment from several ophthalmic conditions, according toward one statement since Teva.

A biosimilar referencing Lucentis possesses stood approved by certain UK Medicines & Healthcare Regulatory Agency for use inside patients with vision loss resulting from neovascular age-related macular degeneration (wet AMD), macular edema diabetic disease, proliferative diabetic retinopathy, macular edema secondary toward retinal vein occlusion nor choroidal neovascularization. A UK is a initial European nation-state for approve Ongavia.

“Teva is delighted in order to bring Lucentis’ foremost biosimilar in ophthalmology for clinicians also patients among each UK,” declared Richard Daniell, executive vice president of Teva Europe Commercial, within a statement. “Our mission is toward improve access for advanced treatments at affordable prices as well as we are creating some role for biosimilars. Ourselves believe whatever unlocking any value of biologics is any novel frontier belonging to medicine also reducing system costs worldwide is the key for expanding patient access. Our group are committed up to providing high quality products and services to support certain eye care community.”

Ranibizumab products occupation through inhibiting vascular endothelial growth factor, whatever be able to lead in order to excessive blood vessel formation among a retina. AMD is a leading cause of blindness among developed countries as well as is estimated up to affect above up to 77 million persons amid Europe near to 2050, creating some significant global burden on healthcare systems as well as societies.

“With any increasing incidence belonging to wet AMD, entity is expected that single considerable amount out of healthcare resources plus careful planning intend seem required for decades for reach,” Teva wrote.

Within a COLUMBUS-AMD Phase 3 multicenter, randomized, double-blind, parallel-group research, Ongavia was comparable up to each reference product within terms made from clinical efficacy since adequately while ocular also systemic safety in patients with AMD.

Another companies looking up to market of them possess ranibizumab biosimilars include Formycon, Intas Pharma, Xbrane Biopharma plus STADA Arzneimittel, Polpharma Biologics and Coherus Biosciences.

Any ranibizumab biosimilar created by Samsung Bioepis in partnership with Biogen (Byoviz; ranibizumab-runa) was a foremost Lucentis biosimilar toward seem approved among the United States, European Union along with Canada.

Ongavia was developed in collaboration with BioEq. Under current partnership, Teva intend have exclusive marketing rights in the UK, EU as well as Canada. The biosimilar is at a lower level review within the European Commission and submission for Canadian approval is expected up to seem completed by the stop out of 2022.

Including Ongavia, Teva currently contains 13 biosimilars within its pipeline, of what 3 are inside phase 3 trials along with 8 are in preclinical development. Among addition for Ongavia, each company’s biosimilar adalimumab, referencing Humira, is undergoing regulatory review and is piece made from some collaboration with Alvotech for commercialization within certain United States.

Teva also possesses some commercialization agreement with Celltrion Healthcare for Herzuma (trastuzumab-pkrb), some biosimilar to Herceptin, as well as Truxima (rituximab-abbs), some biosimilar toward Rituxan. Herzuma was launched in the United States amid March 2020 as well as Truxima was launched among November 2019.