Alvotech secures FDA approval doubling SIMLANDI batch output
- Alvotech received U.S. Food and Drug Administration approval for its new Process 2.0 manufacturing method for SIMLANDI, its biosimilar to Humira.
- The enhanced process more than doubles drug substance output per batch without increasing upstream manufacturing scale, while maintaining demonstrated product comparability.
- Alvotech expects the improvement to free manufacturing capacity for other biosimilars, complementing its October 5 approval to expand U.S. commercial manufacturing at its Reykjavik facility.
Alvotech (NASDAQ:ALVO) received FDA approval for a manufacturing process that more than doubles SIMLANDI drug substance output per batch at its Iceland facility.
The new process increases productivity without expanding upstream production scale, potentially reducing manufacturing costs, although the company disclosed no quantified savings.
“More than doubling drug substance output per batch while maintaining product quality is a significant achievement,” said Alvotech Chief Operating Officer Joseph McClellan.
Process 2.0 will operate in the company's DSM2 manufacturing suite in Reykjavik, following development, transfer and validation demonstrating comparability with the existing process.
Alvotech expects higher batch productivity to free capacity for other biosimilars and support growing demand, although no additional revenue forecast was disclosed.
SIMLANDI, also known as adalimumab-ryvk, is an FDA-approved biosimilar to AbbVie's Humira, with manufacturing capacity supporting commercial supply in the United States.
The latest approval follows an October 5 FDA authorization allowing SIMLANDI drug substance production in a second Reykjavik manufacturing suite, expanding supply flexibility.
