Alvotech secures FDA approval for second SIMLANDI production suite

• Alvotech received U.S. FDA approval to manufacture its SIMLANDI drug substance in a second production suite at its Reykjavik facility.
• The regulatory milestone successfully doubles the manufacturing capacity available to support the U.S. supply of the Humira biosimilar.
• The company expects the FDA to proceed with pending application goal dates for other biosimilars following the closure of its recent facility inspection.

Alvotech (NASDAQ:ALVO) received U.S. FDA approval to manufacture SIMLANDI drug substance in a second production suite at its Reykjavik facility.

SIMLANDI, also widely known by its development name AVT02, is an approved biosimilar referencing Humira.

The regulatory clearance doubles the manufacturing capacity available to support commercial U.S. supply, permitting drug substance production in either the DSM1 or DSM2 suites.

The approval follows the U.S. FDA’s July 2026 closure of its latest Reykjavik inspection with a Voluntary Action Indicated classification.

The company stated it expects the FDA to act on other pending applications according to their respective goal dates.

These upcoming reviews cover AVT05 (Simponi/Simponi Aria), AVT06 (Eylea), AVT03 (Prolia/Xgeva), and AVT16/AVT80 (Entyvio), each remaining subject to individual regulatory decisions.