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Alvotech nine-month revenue falls 23% as FDA accepts AVT80 filing and approves Simlandi process

Alvotech · Wed 11 Nov 2026

The Icelandic biosimilar maker reports $323.4M adjusted revenue to September, keeps its full-year guidance, but now expects to land towards the lower end of the range.

Alvotech reported results for the nine months to 30 September 2026 on 11 November. Adjusted revenue came to $323.4M, compared with $420.0M a year earlier, a fall of about 23%. Cash stood at $61.5M at the period end.

On the regulatory side, the company said the US Food and Drug Administration has accepted the biologics licence application (BLA) for AVT80, its proposed biosimilar to Entyvio (vedolizumab). Acceptance of a BLA means the agency considers the filing complete enough to begin a substantive review; it is not an approval.

Alvotech also said the FDA has approved a new manufacturing process for Simlandi, its adalimumab biosimilar, together with a second drug substance suite at its Reykjavik site. In addition, the company has submitted a marketing application to the European Medicines Agency (EMA) for a proposed biosimilar to Eylea HD.

Alvotech is maintaining its full-year guidance of $650–700M in revenue. It now expects results toward the lower end of that range. The summary provided does not give further detail on the drivers of the revenue decline or on review timelines for the pending filings.

What it means for your team

  • Regulatory teams tracking biosimilars should note the FDA's acceptance of the AVT80 BLA, which signals the start of formal review of a proposed Entyvio biosimilar.
  • The FDA's approval of a new Simlandi process and a second drug substance suite in Reykjavik is a relevant example of post-approval manufacturing changes being cleared for an existing biosimilar.
  • The EMA submission for an Eylea HD biosimilar puts another ophthalmology biosimilar into the European pipeline; no decision timeline was given.
  • Market-access and supply planners should note that Alvotech expects the lower end of its $650–700M guidance, against a lower cash balance of $61.5M.

Company's press release: Alvotech ↗

Article written by VigiEye from the official source (Alvotech). Claims are the company's own. AI-assisted; check the source before acting.

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