Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of the company’s confirmatory clinical study for AVT06 (aflibercept), a biosimilar candidate to Eylea®.
Alvotech notes the objective of the study is 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 (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.
Eylea® (aflibercept) is a widely used biologic for the treatment of a variety of eye disorders including ones which can lead to vision loss or blindness, such as wet AMD, macular edema, and diabetic retinopathy. In 2021, world-wide sales of Eylea® were nearly US$10 billion1.
“We are delighted at the sustained progress of our product pipeline as we continue to leverage our integrated development and manufacturing platform and execute our global biosimilar strategy,” said Robert Wessman, Founder and Executive Chairman.
Joseph McClellan, Chief Scientific Officer, added: “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.”
Alvotech’s current portfolio of eight products and product candidates target treating autoimmune disease, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech’s lead product, AVT02 (adalimumab), a biosimilar to Humira®, the world’s highest grossing medicine (excluding COVID-19 vaccines), has already been approved and launched in Canada and Europe and is expected to launch in the United States on July 1, 20232. Alvotech has also announced positive topline results for AVT04 (ustekinumab), a proposed biosimilar to Stelara®, from both a confirmatory clinical, safety and efficacy study and a pharmacokinetic (PK) study.
About AVT06 (aflibercept)
AVT06 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability. AVT06 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
About AVT02 (adalimumab)
AVT02 is a monoclonal antibody and a biosimilar to Humira® (adalimumab), which inhibits tumor necrosis factor alpha (TNF-alpha). AVT02 is not approved outside of the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada. AVT02 dossiers are under review in multiple countries; in the U.S. the initial BLA for approval as a biosimilar is in deferred status, pending the result of FDA inspections.
About AVT04 (ustekinumab)
AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines called interleukin-12 and interleukin-23 that are involved in inflammatory and immune responses. Abnormal regulation of these cytokines has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. AVT04 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
2Subject to regulatory approval