Key Takeaways
- Alvotech shares rose 13% after the FDA approved a second Reykjavik production suite for Simlandi, its Humira biosimilar, doubling the capacity available for U.S. supply.
- The more important news is that the approval suggests the factory problems that held up Alvotech’s U.S. pipeline are behind it.
- Between November 2025 and January 2026, the FDA rejected Alvotech’s Simponi, Eylea and Prolia/Xgeva biosimilars over deficiencies at that same plant.
- FDA decisions on those three resubmitted filings are expected in the fourth quarter of 2026, so they’re the next thing to watch.
Alvotech (ALVO) shares are up about 13% today after the FDA approved more U.S. manufacturing capacity for its Humira biosimilar.
But that’s just the tip of the iceberg here.
What exactly happened
Before Monday’s open, Alvotech announced that the FDA had approved a supplement to its application for SIMLANDI, its biosimilar to Humira.
The approval lets Alvotech make SIMLANDI’s drug substance (the active ingredient) for the U.S. in a second suite at its Reykjavik plant. That suite, DSM2, already makes product for Europe.
As Alvotech CEO Lisa Graver put it:
“The addition of DSM2 effectively doubles the drug substance manufacturing capacity available to support U.S. supply…”
That means more product for Teva Pharmaceutical Industries (TEVA), which has the exclusive rights to sell SIMLANDI in the U.S.
This plant was the problem
This Reykjavik plant has been Alvotech’s biggest headache.
A July 2025 inspection found deficiencies at the site. After that, the FDA rejected Alvotech’s biosimilars to Simponi, Eylea and Prolia/Xgeva in November 2025, December 2025 and January 2026.
Alvotech went to work on the site, and the three filings went back to the FDA in June. In July, the FDA closed its latest inspection there as “Voluntary Action Indicated.” (That means inspectors found issues, but none serious enough for the agency to act on.)
Monday’s approval is another FDA sign-off for that same plant. Alvotech says it now expects the FDA to act on its pending filings by their goal dates. That includes a fourth filing, for an Entyvio biosimilar.
What’s next
In its first-half results, Alvotech said it expects FDA decisions on the three resubmitted filings this quarter. So this may be just the first of a string of good headlines for the company. Which is great news for any patient struggling with drug prices.
And also for Alvotech shareholders. As you can see, analysts expect solid growth in the years ahead.
Of course, the real test comes when the FDA rules on the remaining filings.
So what is Alvotech stock actually worth?
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Disclaimer:
Please note that the articles on TIKR are not intended to serve as investment or financial advice from TIKR or our content team, nor are they recommendations to buy or sell any stocks. We create our content based on TIKR Terminal’s investment data and analysts’ estimates. Our analysis might not include recent company news or important updates. TIKR has no position in any of the stocks mentioned. Thank you for reading, and happy investing!
