FDA approves second production suite for Alvotech’s Humira biosimilar in the United States
Alvotech announced that the U.S. Food and Drug Administration has cleared a supplement to its Biologics License Application, allowing the drug substance for SIMLANDI® (AVT02) to be produced in a new production suite at its Reykjavik plant. The new suite, DSM2, doubles the company’s U.S. manufacturing capacity for the product and adds flexibility for supply. The approval also confirms that issues identified during the July 2026 FDA inspection of the facility have been resolved. Alvotech expects the agency to consider other pending biosimilar applications linked to the same site according to their target timelines.
Why it matters
The company says the added capacity will support U.S. commercial supply of SIMLANDI® and may accelerate regulatory actions on its other biosimilar candidates. Investors should note that the increased manufacturing flexibility could improve revenue potential for the Humira biosimilar and reduce supply‑risk concerns.
Key facts
- 1The FDA approved a supplement to the BLA for AVT02, enabling drug substance manufacturing in a second Reykjavik production suite. globenewswire.com
- 2The new suite, DSM2, doubles Alvotech’s U.S. drug‑substance capacity for SIMLANDI®. globenewswire.com
- 3The approval confirms that inspection‑related matters from the July 2026 FDA inspection of the Reykjavik facility have been resolved. globenewswire.com
- 4Alvotech expects the FDA to act on other pending applications (AVT05, AVT06, AVT03, AVT16/AVT80) according to their respective goal dates. globenewswire.com
- 5Lisa Graver is the Chief Executive Officer of Alvotech. globenewswire.com
Summary written by AlphAI from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.