Alvotech (ALVO) and its partner Advanz Pharma submitted AVT29 to the European Medicines Agency on 14 October 2026, according to a company release issued the same day. AVT29 is a proposed biosimilar to Eylea 8 mg, the higher-dose form of aflibercept that is sold as Eylea HD in the United States. The application covers Europe only.

The filing is a line extension to the existing European marketing authorization for Mynzepli, Alvotech's biosimilar to the 2 mg form of Eylea. The European Commission approved Mynzepli in August 2025. Advanz Pharma holds commercial rights in Europe, with semi-exclusive rights in Germany and France. Alvotech is responsible for development and commercial supply of AVT29.

What the filing claims

The release calls the filing a first. Alvotech chief executive Lisa Graver said: "To our knowledge, this is the first regulatory submission anywhere in the world for a proposed biosimilar to Eylea 8 mg." That is a company statement based on its own knowledge, and the release cites no independent search of other filings.

As calculated by Trend & Ticker, the new filing came about 14 months after the Mynzepli approval. A line extension adds to a product that regulators have already reviewed, so the file builds on an existing record rather than starting one.

Readers following the Eylea franchise can compare this step with the 2 mg program, which Alvotech and Advanz have already taken through an approval in Europe.

What the release leaves out

The release describes no clinical trial and no data for AVT29. It states that the product is investigational, has not received regulatory approval, and that biosimilarity has not yet been established.

No review timeline is given. The release does not say when the agency will decide. It does explain the target. Under the approved European product information, the 8 mg form allows dosing every 16 weeks for some patients, against eight weeks for 2 mg. Citing Regeneron results, the release puts the 8 mg form at about 57% of combined Eylea 2 mg and 8 mg sales in the second quarter of 2026, up from about 30% a year earlier.

Steffen Wagner, Advanz Pharma's chief executive, called the filing "an important milestone in our partnership with Alvotech." The next public fact will be the agency's validation or decision, and the release sets no date for either.