Coherus plans to file a Biologics License Application for FYB203 later in 2023 in preparation for an anticipated 2025 launch.
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 for FYB203 later in 2023 in preparation for an expected 2025 launch, if the application is approved.
The transaction between the 2 companies is expected to be completed in the first quarter of 2023.
“This additional ophthalmology product will allow us to broadly target the entire $7 billion class of anti-vascular endothelial growth factor [VEGF] products, substantially increasing our market opportunity to support mid- to long-term growth and revenue potential,” said Denny Lanfear, CEO of Coherus.
According to Lanfear, the agreement extends the company's commitment to “expand choice and 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 commercialization of Udenyca (pegfilgastin) and the recent launch of Cimerli (ranibizumab-eqrn), the latter of which is the first and only FDA-approved biosimilar with ranibizumab (Lucentis, Genentech Inc.).
“The addition of an Eylea biosimilar will be highly synergistic with our retina portfolio, leveraging our existing dedicated retina sales team and patient services hub to enable successful access 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 expected in the next few weeks. MAGELLAN-AMD is a randomized, double-blind, multicenter study designed to evaluate the efficacy and safety of FYB203 compared to the aflibercept for safety, efficacy and immunogenicity in patients with neovascular age-related macular degeneration.
A total of 434 patients will receive 1 intravitreal injection of FYB203 every 4 weeks for the first 3 doses, followed by 1 intravitreal injection every 8 weeks through study completion. The primary outcome assessment is a change from baseline in best corrected visual acuity at 8 weeks.