Coherus BioSciences and Klinge Biopharma have entered into an agreement by which Coherus BioSciences will acquire the exclusive US commercialization rights from Klinge Biopharma for FYB203, a biosimilar candidate to aflibercept (Eylea, Regeneron Pharmaceuticals).
Coherus plans to file a Biologics License Application (BLA) for FYB203 later in 2023 within preparation for an expected 2025 launch, if the application is approved.
The transaction between the 2 companies is expected in order to be completed in the first quarter of 2023.
“This additional ophthalmology product will allow us to broadly target the entire $7 billion class associated with anti-vascular endothelial growth factor [VEGF] products, substantially increasing our market opportunity to support mid- in order to long-term growth and revenue potential, ” said Denny Lanfear, CEO of Coherus.
According to Lanfear, the contract extends the particular company’s commitment to “expand choice plus improve access for physicians and patients seeking high-quality, cost-effective alternatives in anti-VEGF therapies throughout the continuum of care. ”
This action, when approved, will extend Coherus’s presence in the biosimilar market with the commercializatio of Udenyca (pegfilgastin) and the recent release of Cimerli (ranibizumab-eqrn), the latter of which is the first and only FDA-approved biosimilar along with Lucentis (ranibizumab, Genentech Inc. ).
“The addition associated with an Eylea biosimilar will be highly synergistic with our retina portfolio, leveraging our own existing dedicated retina sales team and patient services hub to enable successful entry and reimbursement, ” said Paul Reider, the chief commercial officer of Coherus.
According to the company, FYB203 currently is being evaluated in a phase 3 clinical trial ( MAGELLAN-AMD ) and topline results are anticipated in the next few weeks. MAGELLAN-AMD is the randomized, double-blind, multicenter study designed to evaluate the efficacy and safety of FYB203 compared to the aflibercept for security, efficacy plus immunogenicity in patients with neovascular age-related macular degeneration.
A total of 434 patients will certainly receive 1 intravitreal injection of FYB203 every 4 weeks for the first 3 doses, followed by 1 intravitreal injection every 8 weeks through research completion. The particular primary outcome assessment is a change through baseline inside best corrected visual acuity at 8 weeks.