REG-Alvotech receives FDA approval for new SIMLANDI® manufacturing process that more than doubles output per batch
Alvotech received FDA approval of a new manufacturing process (Process 2.0) for SIMLANDI, its Humira biosimilar, in its DSM2 suite in Reykjavik. The process more than doubles drug substance output per batch without changing upstream manufacturing scale, with demonstrated comparability in quality, safety and efficacy.
Key figures
- Drug Name
- SIMLANDI (adalimumab-ryvk)
- Output improvement
- more than doubles drug substance output per batch
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