German drug maker Formycon released its third quarter financial results on Monday, and reported that it plans to launch its biosimilar ranibizumab candidate, FYB201, in the United States in 2020.
German drug maker Formycon released its third quarter financial results on Monday, and reported that it plans to launch its biosimilar ranibizumab candidate, FYB201, in the United States in 2020.
Formycon says that FYB201, referenced on Roche’s Lucentis, is the world’s only biosimilar candidate for ranibizumab that has progressed to a phase 3 clinical trial, and that “an innovative application system underpinned by the company’s own patent applications” puts the drug maker in a “highly promising position” to capture a share of the market for anti—vascular endothelial growth factor (anti-VEGF) therapy for eye disorders.
If approved in the US marketplace, Formycon’s drug will compete with Lucentis, which is approved to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. Lucentis has already faced significant competition from another anti-VEGF therapy, Regeneron’s Eylea (aflibercept), which some investors predict could earn up to $5 billion in sales by 2023.
Formycon is also taking aim at Eylea; the biosimilar developer reports that it is in the preclinical development phase with FYB203, a biosimilar aflibercept candidate. Formycon says that it is currently completing measures to establish its manufacturing process for the drug, and predicts that it is on track to launch a biosimilar in the US marketplace when Eylea reaches US patent expiry in 2023.
The company is also undertaking development of biosimilars to treat other conditions; Formycon is currently developing FYB202, a proposed ustekinumab biosimilar. The molecule, referencing Stelara, is a human interleukin-12 and -23 antagonist that, if approved for all indications of the reference product, will treat moderate to severe plaque psoriasis in adults and adolescents, active psoriatic arthritis, and moderately to severely active Crohn’s disease. Formycon is developing its biosimilar candidate under a partnership with Santo Holding GmbH; under the companies’ agreement, Formycon is contributing 30% of development costs to this project.
Ranibizumab Biosimilar Shows Reduced Efficacy vs Aflibercept in nAMD
April 3rd 2025The ranibizumab biosimilar Ongavia exhibited significantly less improvement in visual acuity and retinal thickness compared with aflibercept (Eylea) in treating neovascular age-related macular degeneration (nAMD), highlighting a potential trade-off between economic savings and clinical efficacy.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Real-World Data Confirm Safety of Switching Between Ranibizumab Biosimilars
March 19th 2025Patients with diabetic macular edema previously treated with a ranibizumab biosimilar in India experience comparable safety and efficacy after being switched to another ranibizumab biosimilar, demonstrating real-world safety of biosimilar-to-biosimilar switching.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.