FDA Approves Second Manufacturing Suite for Alvotech's Humira Biosimilar, Doubling U.S. Capacity
ALVO sits 85% above its 52-week low of $2.94.
Summary
The FDA approved a supplement to Alvotech's BLA for AVT02 (SIMLANDI), allowing drug substance production in a second suite (DSM2) at its Reykjavik facility. This doubles U.S. manufacturing capacity for the Humira biosimilar and provides supply flexibility. The approval further confirms resolution of the July 2026 inspection issues that had been a major overhang. With the facility now cleared, the FDA can proceed on pending applications for AVT05, AVT06, AVT03, and AVT16/AVT80 according to their goal dates. This is a meaningful operational and regulatory milestone that de-risks the company's near-term pipeline and supports revenue growth.
At the time of this announcement, ALVO was trading at $5.44 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.1B. The 52-week trading range was $2.94 to $9.05. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.