The two companies have announced an exclusive agreement for Polifarma to commercialize AVT06, the proposed biosimilar to Eylea, in Turkey.
Alvotech and Polifarma have announced an exclusive agreement for the commercialization of AVT06 in Turkey. According to the agreement, Alvotech will be responsible for development and manufacture, while Polifarma will handle market registration and commercialization.
According to a press release from Alvotech,1 AVT06 is a recombinant fusion protein and a biosimilar candidate to Eylea (aflibercept). AVT06 binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability.
In the press release, Robert Wessman, CEO of Alvotech talked about the partnership.
“It is a pleasure to join forces with Polifarma in the commercialization of a potential therapy in eye disease,” said Wessman. “We are committed to providing better patient access to affordable biologics, and this agreement will allow us to better serve the growing and important Turkish market.”
“This agreement with Alvotech allows us to expand our portfolio and further strengthen our position in the ophthalmology area. We are excited to have the opportunity to commercialize this product in Turkey," said Mehmet Asri, CEO of Polifarma.
In July 2022, Alvotech announced the initiation of a patient study to compare AVT06 and Eylea in terms of efficacy, safety and immunogenicity in adult patients with neovascular (wet) age-related macular degeneration (AMD).
The study, named ALVOEYE, is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study, and is expected to enroll approximately 444 participants globally. The study’s primary endpoint is the change in best corrected visual acuity (BVCA) from baseline to week 8.
Joseph McClellan, Chief Scientific Officer at Alvotech, noted the importance of the trial.
“The initiation of this patient study marks an important step in the development of our AVT06 biosimilar candidate, and demonstrates Alvotech’s commitment to developing biosimilars addressing key therapeutic areas in order to improve the lives of people around the world,” said McClellan.