Alvotech (NASDAQ: ALVO), 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 European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg).

Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.

"CHMP’s positive opinion takes us a step closer to being able to market our proposed biosimilar in Europe, which is excellent news for patients and their caregivers. Alvotech looks forward to increasing access to this vital biologic treatment for eye disorders," said Joseph McClellan, Chief Scientific Officer of Alvotech.

“We are pleased with the CHMP’s positive opinion, which marks an important milestone in our mission to bring high-quality, specialist medicines to patients across Europe,” said Nick Warwick, Chief Medical Officer of Advanz Pharma.

The CHMP opinion recommends granting of a marketing authorization for AVT06 intended for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

Alvotech is responsible for the development and commercial supply of the proposed biosimilar. Advanz Pharma is responsible for registration and has exclusive commercialization rights for most countries in Europe.

In 2024, global sales of Eylea® were about US$9 billion, and one third of these sales were in Europe [1].

In January 2024 Alvotech announced positive top-line results from a confirmatory clinical study with AVT06 (AVT06-GL-C01) 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® [2].

Alvotech is also developing AVT29, a proposed biosimilar to Eylea® HD, a higher dose (aflibercept 8 mg) aflibercept. Advanz has licensed the distribution rights from Alvotech for both biosimilar candidates, for the same territory.