Alvotech gains FDA approval for second SIMLANDI production suite
The Reykjavik approval doubles drug substance capacity available for U.S. supply; separate biosimilar applications remain under FDA review.
Adrian Kessler
SIMLANDI drug substance can now be made in either of two Reykjavik production suites after Alvotech NASDAQALVO said Monday the U.S. Food and Drug Administration approved a manufacturing supplement for its adalimumab biosimilar. The added suite doubles the drug substance capacity available to support U.S. supply, according to the company's Oct. 5 announcement.
The approval adds DSM2 to the existing DSM1 suite as an authorized source for U.S. commercial supply. Alvotech NASDAQALVO shares closed at US$5.45 on Nasdaq at 4 p.m. EDT on Oct. 2, before the announcement. A regular-session share reaction to the Oct. 5 decision was not yet available.
Alvotech develops and manufactures biosimilar medicines in Iceland for commercial partners serving markets around the world. SIMLANDI is its U.S. brand for AVT02, an interchangeable biosimilar to Humira approved in 2024, according to the company's joint announcement with its U.S. partner.
The Oct. 5 action authorizes another manufacturing source for an already approved medicine. It does not approve any of Alvotech's separate pending U.S. biosimilar applications, which the company says remain subject to their own FDA reviews and decisions.
Inspection Closure Preceded The Capacity Decision
DSM2 handles cell culture and purification, the stages that produce the drug substance used in the finished medicine. Alvotech said the suite was already approved to make commercial drug substance for European markets, including AVT02, AVT03 and AVT05. U.S. authorization now lets the company allocate AVT02 production between its two Reykjavik suites.
“The addition of DSM2 effectively doubles the drug substance manufacturing capacity available to support U.S. supply and provides greater flexibility for commercial supply of AVT02 to the U.S. market,” Alvotech chief executive Lisa Graver said in the Oct. 5 release.
The company's July 29 inspection update said the FDA had closed its most recent Reykjavik inspection with a Voluntary Action Indicated classification after a May visit. Alvotech describes Monday's supplement approval as further confirmation that the facility's inspection issues were resolved. That account comes from the company release; the FDA's underlying approval letter was not available in the material reviewed.
The manufacturing issue had already affected sales. In its Aug. 19 results, Alvotech said its improvement program reduced product availability in the first half of 2026, when adjusted revenue fell to US$211.9 million from US$306.1 million a year earlier. Cash stood at US$142.8 million on June 30, and the company said manufacturing had returned to planned operating levels by the end of that quarter.
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Teva Pharmaceuticals Is Alvotech's U.S. Partner
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. NYSETEVA, is Alvotech's strategic partner for exclusive U.S. commercialization of SIMLANDI, the companies said in their 2024 approval announcement. The partners said Alvotech handles the product's development and manufacturing.
Another U.S. adalimumab biosimilar is AMJEVITA, which Amgen Inc. NASDAQAMGN identifies on its product website as an FDA-approved Humira biosimilar. Both products compete in a treatment category spanning inflammatory conditions, but Monday's FDA action concerned only Alvotech's manufacturing site.
The listed U.S. biosimilar names entered Monday from different Oct. 2 closes: Teva NYSETEVA shares were US$39.53 on the NYSE at 4 p.m. EDT. Amgen NASDAQAMGN shares were US$403.04 on Nasdaq at 4 p.m. EDT on Oct. 2. Those prices precede Alvotech's announcement.
Alvotech's August update said it anticipated FDA decisions in the fourth quarter of 2026 on resubmitted applications for AVT05, AVT06 and AVT03. The company said in the Oct. 5 release that those applications remain subject to individual decisions, so the SIMLANDI supplement establishes no outcome for them.
Alvotech is scheduled to release third-quarter results on Nov. 11. That report will show whether its return to planned manufacturing levels lifted product revenue before the separate FDA decisions it expects in the fourth quarter.
