FDA approves expanded manufacturing capacity for Alvotech’s Simlandi
The U.S. Food and Drug Administration has authorized a second manufacturing line at Alvotech’s Reykjavik facility, doubling production capacity for the Humira biosimilar Simlandi.
Alvotech has received regulatory approval from the U.S. Food and Drug Administration (FDA) to utilize a second production suite at its Reykjavik facility for the manufacture of AVT02, marketed in the U.S. as Simlandi. This expansion doubles the company's available drug substance capacity specifically for the American market.
The authorization confirms the resolution of previous inspection-related concerns at the Icelandic site. CEO Lisa Graver stated that the approval enhances operational flexibility and provides the company with a more stable supply chain for its adalimumab biosimilar.
Following the FDA’s closure of its most recent inspection in July 2026, Alvotech expects the regulator to proceed with decisions on other pending applications. The company has several additional biosimilar candidates in its pipeline, including versions of Simponi, Eylea, and Prolia, which remain subject to individual FDA review cycles.