Alvotech Receives FDA Approval for New SIMLANDI® Manufacturing Process That More Than Doubles Output Per Batch
Key Highlights
- ➤FDA approves SIMLANDI Process 2.0 for Alvotech’s Reykjavik manufacturing suite
- ➤New process more than doubles drug substance output per batch
- ➤Alvotech maintains product quality, safety and efficacy through validated process
- ➤Process 2.0 frees capacity for other products and improves supply flexibility
Expert Statements
Joseph McClellan, Chief Operating Officer of Alvotech
“More than doubling drug substance output per batch while maintaining product quality is a significant achievement that reflects the expertise of our process development and manufacturing teams.”
Joseph McClellan, Chief Operating Officer of Alvotech
“The new process allows us to manufacture the same quantity of drug substance in fewer batches, freeing up capacity to support other products in our portfolio, making better use of our existing infrastructure and giving us greater flexibility to respond to growing demand.”
Joseph McClellan, Chief Operating Officer of Alvotech
“Together with the recent FDA approval of additional manufacturing capacity, this demonstrates the strength of our operations in Reykjavik and reinforces our ability to deliver reliable supply to our commercial partners as demand for our biosimilars continues to grow.”
REYKJAVIK, Iceland and LONDON, Oct. 20, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has approved a new manufacturing process for SIMLANDI(® )(adalimumab-ryvk), Alvotech’s biosimilar to Humira(®) (adalimumab).
The FDA approval allows Alvotech to introduce Process 2.0 for the manufacture of adalimumab drug substance in its DSM2 manufacturing suite in Reykjavik, Iceland. The new process more than doubles drug substance output per batch without changing the upstream manufacturing scale.
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