Alvotech Initiates Patient Study for Proposed Biosimilar for Eylea

Alvotech recently announced the initiation of the company’s confirmatory clinical study for AVT06 (aflibercept), a biosimilar candidate to Eylea. 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 that 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 $10 billion.

“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 US on July 1, 2023. 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.

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.

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 US, the initial BLA for approval as a biosimilar is in deferred status, pending the result of FDA inspections.

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.

Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU and select other territories), Fuji Pharma Co., Ltd (Japan), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, visit www.alvotech.com.