Alvotech Enters Commercialization Agreement With Polifarma for Proposed Biosimilar to Eylea

Alvotech recently announced it has entered an exclusive agreement with Polifarma Ilac San. ve tic. A.S. for the commercialization in Turkey of AVT06, a proposed biosimilar to Eylea (aflibercept).

“It is a pleasure to join forces with Polifarma in the commercialization of a potential therapy in eye disease,” said Robert Wessman, Chairman and CEO of Alvotech. “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.”

“Polifarma has been contributing to public health and the health sector in the world for 37 years with its motto of We stand by life. 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,” added Mehmet Asri, CEO of Polifarma.

According to the agreement, Alvotech will be responsible for development and manufacture, while Polifarma will handle market registration and commercialization.

AVT06 is a biosimilar candidate currently in clinical development. 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).

AVT06 is a recombinant fusion protein and a biosimilar candidate to Eylea (aflibercept), which 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.

Polifarma is the market leader of hospital products in Turkey and has a 37-year history, with 100% domestic capital. While developing its IV drug portfolio, Polifarma started to grow in the prescribed markets. As a leading brand in the Turkish health sector, Polifarma produces 350 million boxes per year at its 77 thousand square meter facility in Ergene/Tekirdağ. Besides manufacturing ampoules, vials and pre-filled syringes (PFS), Polifarma has 600 licensed products in all forms and 12 certificates in 15 therapeutic areas. Polifarma offers innovative solutions, such as Turkey’s first lipid product and the world’s first three-chamber parenteral nutrition solution and CAPD device. Exporting to 70 countries, Polifarma’s vision is to become a global leader by 2025 and maintain its position with EU-GMP compliance and a commitment to quality and technology.

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), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), 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.