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.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
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.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.