REG-Alvotech receives FDA approval for new SIMLANDI® manufacturing process that more than doubles output per batch
Globe Newswire•20/10/2026•04:30 ET
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Key Highlights
- ➤FDA approves Alvotech’s Process 2.0 for SIMLANDI drug-substance manufacturing
- ➤Process 2.0 more than doubles output per batch without changing manufacturing scale
- ➤New process frees capacity for other biosimilars and supports growing demand
- ➤FDA approval confirms comparability while maintaining product quality, safety, and efficacy
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.”
Enhanced process increases manufacturing productivity and frees up capacity to support growing demand across Alvotech’s biosimilars portfolio
REYKJAVIK, Iceland and LONDON, UK (October 20, 2026) - 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).
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