Alvotech  a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, announced that the companies have entered into an exclusive partnership agreement regarding the supply and commercialization of Alvotech’s proposed biosimilar to Eylea^® (aflibercept). Alvotech is currently developing AVT06, a proposed biosimilar to Eylea^® low dose (2 mg) and AVT29, a biosimilar candidate for Eylea^® high dose (8 mg).

Eylea^® is a widely used biologic for the treatment of eye disorders, including diseases which can lead to vision loss or blindness, such as wet AMD, macular edema, and diabetic retinopathy. In 2023, reported sales of Eylea^® in Europe were $2.9 billion [1].

Under the agreement, Alvotech will be responsible for development and commercial supply of AVT06 and AVT29, and Advanz Pharma will be responsible for registration and commercialization. Advanz Pharma has exclusive commercialization rights in Europe, except for Germany and France where the rights are semi-exclusive. The commercialization agreement includes an upfront payment to Alvotech with subsequent payments upon certain development and commercialization milestones.

“We value our growing partnership with Advanz Pharma which started early last year and has now been expanded to a total of seven biosimilar candidates. We share a common vision for the growth of the biosimilars market and a strong commitment to providing broader patient access to more affordable biologics,” said Anil Okay, Chief Commercial Officer of Alvotech.

Susanna El-Armale, Chief Corporate Development Officer at Advanz Pharma, said: “We are excited to reinforce our collaboration with Alvotech by adding an impactful and meaningful product to our growing pipeline. This partnership leverages our combined strengths and reinforces Advanz Pharma as a partner of choice for the commercialization of specialty pharmaceuticals in Europe.”

In January 2024 Alvotech announced positive top-line results from a confirmatory patient study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with 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^®.         

In February 2023 Alvotech and Advanz Pharma announced that the companies had entered into an exclusive agreement for the commercialization of AVT23, a proposed biosimilar to Xolair^®(omalizumab). The agreement covers the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand. In May 2023 Alvotech and Advanz Pharma announced that the companies had expanded their partnership to include biosimilar candidates to Simponi^®(golimumab) and Entyvio^® (vedolizumab) and as well as three additional early-stage, undisclosed biosimilar candidates.