StocksMedium•5 October 2026•
1 min read
FDA Approves Expanded Manufacturing Capacity for Alvotech’s SIMLANDI Biosimilar
Key Facts
1The FDA approved additional manufacturing capacity in Reykjavik for the drug substance of SIMLANDI, Alvotech's biosimilar to Humira.
The FDA approved additional manufacturing capacity in Reykjavik for the drug substance of SIMLANDI, Alvotech's biosimilar to Humira. GlobeNewswire reported that the approval allows Alvotech to utilize a second drug substance suite in its facility to supply the U.S. market, expanding its commercial supply capabilities.
ALVO closed at $5.45 on October 2, 2026, with a session high of $5.7 and a low of $5.43. This regulatory milestone for the Reykjavik facility aims to ensure supply chain scale and provides greater flexibility across the company's manufacturing operations for the U.S. market.