Alvotech Wins FDA Nod to Double Simlandi Production

Alvotech said FDA has approved a supplement to its Biologics License Application for Simlandi (adalimumab-ryvk), its interchangeable biosimilar to Humira, authorizing a second drug-substance production suite at the company's Reykjavik, Iceland facility for the US market. The company announced the approval 5 October 2026, framing it as both a capacity expansion and a vote of confidence in a plant that has had its own run-ins with FDA inspectors.

What the supplement does

DSM2, the suite the supplement brings online for US-bound supply, handles cell culture and purification — the stages that produce the drug substance later formulated into finished Simlandi. It was already approved to make commercial drug substance for European markets, including AVT02 and two other Alvotech biosimilars, AVT03 and AVT05. The supplement extends that authorization to US commercial supply, so AVT02 drug substance bound for the American market can now come from either Reykjavik suite rather than DSM1 alone. Alvotech frames the practical effect as doubling the drug-substance capacity available to support US supply and adding flexibility it did not have with a single qualified line.

A plant with a documented inspection history

The approval lands against a specific backdrop at the Reykjavik facility. FDA closed its most recent routine current Good Manufacturing Practice surveillance inspection there, conducted in May 2026, with a Voluntary Action Indicated classification in July 2026 — FDA's middle tier, where inspectors note objectionable conditions but do not require a written response or formal regulatory action. Alvotech has publicly tied that VAI outcome, and now this supplement approval, to the idea that the plant's compliance posture has improved; the company's investments in manufacturing and quality systems, it has said, were what allowed it to resubmit US biologics license applications for other candidates in June 2026. None of that erases the facility's earlier history of FDA findings; it is the context in which a new capacity-expanding approval should be read, not a replacement for it.

Why this is a single-source story, and what that means

Regulatory News corroborates every load-bearing fact across independent sources before publishing. For this story, the surrounding facts clear that bar: Simlandi's original FDA approval as an interchangeable Humira biosimilar, in February 2024, and the Reykjavik facility's May 2026 inspection and July 2026 VAI classification, are each independently reported outside Alvotech's own channels. The 5 October 2026 supplement approval itself is not: as of publication, it appears only in Alvotech's own announcement and its wire syndications, with no independent trade-press account located. Regulatory News is reporting it as what it is — the company's own disclosure of an FDA action affecting its manufacturing license, the kind of material fact a public company has reason to state accurately — while flagging plainly that independent confirmation has not yet surfaced. Readers should weigh the approval claim accordingly until it does.

Frequently asked questions

What did FDA approve on 5 October 2026?

A supplement to Alvotech's BLA for AVT02 (Simlandi), authorizing a second Reykjavik drug-substance suite, DSM2, for US commercial supply. Alvotech announced the approval; Regulatory News found no independent trade-press confirmation of the approval itself at publication.

What does the supplement change?

AVT02 drug substance for the US market can now be made in either Reykjavik suite instead of one, which Alvotech describes as doubling available US-bound drug-substance capacity.

Why does the facility's inspection history matter here?

FDA closed a May 2026 routine GMP inspection of the Reykjavik facility with a Voluntary Action Indicated classification in July 2026. Alvotech presents the new supplement approval as further evidence that the facility's prior inspection findings are resolved.

What is Simlandi?

Alvotech's biosimilar to AbbVie's Humira, approved by FDA on 23 February 2024 as the first high-concentration, citrate-free biosimilar to Humira with interchangeable status, commercialized in the US with Teva.