Advanz Pharma & Alvotech Receive European Approval for Mynzepli, Biosimilar to Eylea

Alvotech and Advanz Pharma Holdco Limited recently announced the European Commission has approved Mynzepli as a biosimilar to Eyle (aflibercept), in a pre-filled syringe and vial.

“Timely access to effective therapies is essential for individuals affected by retinal diseases. With millions of Europeans impacted, the approval of Mynzepli represents important progress in providing innovative and affordable treatment options. This helps to ensure that patients throughout Europe have improved access to vision-preserving care, regardless of financial or logistical barriers,” said Joseph McClellan, Chief Scientific and Technical Officer of Alvotech.

Nick Warwick, Chief Medical Officer of Advanz Pharma, added “The approval of Mynzepli marks an important milestone in our mission to broaden access to high-quality and affordable medicines for patients across Europe.”

The centralized marketing authorization is valid in all European Economic Area (EEA) countries, including the 27 member states of the European Union, as well as Norway, Iceland and Lichtenstein. In 2024, global sales of Eylea were about $9 billion, and one third of these sales were in Europe.

Mynzepli is approved for all adult indications approved for the reference biologic, neovascular (wet) age-related macular degeneration (AMD), or visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME) or myopic choroidal neovascularization (myopic CNV). Mynzepli will be available as a 40 mg/mL solution for injection in a pre-filled syringe and 40 mg/mL solution for injection in a vial.

In January 2024 Alvotech announced positive top-line results from a confirmatory clinical study with its biosimilar candidate to Eylea, known as AVT06, comparing the efficacy, safety, and immunogenicity of the proposed biosimilar to Eylea in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea. The European Commission’s decision to issue a marketing authorization came after the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on approving AVT06, as Mynzepli (aflibercept). Dossiers for AVT06 are currently under review in multiple countries globally, including the US and Japan.

Mynzepli (aflibercept) is a recombinant fusion protein which has now been approved in the European Economic Area as a biosimilar to Eylea (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability.

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 includes eight disclosed 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.

Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Advanz Pharma’s headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, biosimilars & specialty generics, and originator brands. Advanz Pharma’s products cover a broad range of therapeutic areas, including hepatology, rheumatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Advanz Pharma’s ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with Advanz Pharma’s ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to Advanz Pharma’s dedicated and highly qualified employees, acting in line with Advanz Pharma’s company values of entrepreneurship, speed, and integrity.