Another ranibizumab biosimilar, Byooviz, is approved, but Coherus’ product is the first deemed interchangeable, which involves additional FDA requirements that allow substitution without intervention of the prescribing clinician.
The Coherus biosimilar ranibizumab-eqrn, which references the injectable Lucentis, received FDA approval late Tuesday, bringing more competition to the ophthalmology market after years in which expensive injectable therapies for retinal conditions brought in billions in sales.
The vascular endothelial growth factor (VEGF) inhibitor, to be sold as Cimerli, was desginated as an interchangeable biosimilar across all 5 indications, with 12 months’ exclusivity on interchangeability. Another ranibizumab biosimilar, Byooviz, is approved, but Coherus’ product is the first deemed interchangeable, which involves additional FDA requirements that allow substitution without intervention of the prescribing clinician, subject to state pharmacy laws. Lucentis had sales of $1.61 billion in 2020.
In a statement, Coherus’ Chief Commercial Officer Paul Reider said the status will ensure greater access and choice for patients with retinal disease. “Coherus is the only company in the $7 billion anti-VEGF ophthalmology market with a demonstrated track record of US commercial biosimilar success,” he said.
The company plans to launch Cimerli in October in both 0.3 mg and 0.5 dosages. Retinal indications for which Cimerli is interchangeable are: neovascular (wet) age-related macular degeneration, or AMD; macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
The product is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products.
In its statement, Coherus said approval and the interchangeable desgination were based on several studies, including the COLUMBUS-AMD study appearing in Ophthalmology. This head-to-head study showed Cimerli met its primary end point of change from baseline in best corrected visual acuity at week 8 compared with the reference ranibizumab.
Eye on Pharma: EU Biosimilar Approval, Launches and Product Returns, Denosumab Switching Data
July 10th 2024The European Union approves a tocilizumab biosimilar and the US sees another launch, Genentech’s ophthalmology biobetter returns to the market, and Samsung Bioepis shares data on switching to its denosumab biosimilar.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth
March 14th 2024In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.
Eye on Pharma: Canadian Aflibercept Settlement; Sandoz Acquires Cimerli; Payer Chooses Cyltezo
March 6th 2024Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.