Formycon Projects US Biosimilar Ranibizumab Launch 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.