REG-FDA approves additional U.S. manufacturing capacity for SIMLANDI®, Alvotech’s biosimilar to Humira®
Globe Newswire•05/10/2026•04:00 ET
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Key Highlights
- ➤FDA approves AVT02 U.S. drug substance manufacturing in Alvotech’s second Reykjavik suite
- ➤DSM2 doubles drug substance capacity available to support U.S. SIMLANDI supply
- ➤FDA’s July 2026 Reykjavik inspection closed with Voluntary Action Indicated classification
- ➤Alvotech expects FDA action on other facility-linked pending applications by their goal dates
Expert Statements
Lisa Graver, Chief Executive Officer of Alvotech
“This approval is important both operationally and as a further regulatory milestone for our Reykjavik facility.”
Lisa Graver, Chief Executive Officer of Alvotech
“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.”
Lisa Graver, Chief Executive Officer of Alvotech
“It also reflects the significant progress our teams have made in strengthening quality systems and manufacturing operations at the site.”
Approval enables AVT02 drug substance for U.S. commercial supply to be manufactured in either of Alvotech’s two Reykjavik drug substance suites
Further confirms resolution of FDA inspection-related matters at the Reykjavik site
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