Alvotech Receives FDA Approval for New SIMLANDI® Manufacturing Process That More Than Doubles Output Per Batch
Alvotech received FDA approval of Process 2.0 for manufacturing the drug substance of SIMLANDI (adalimumab-ryvk), its biosimilar to Humira. The new process more than doubles drug substance output per batch at the company's DSM2 suite in Reykjavik without changing upstream manufacturing scale, with demonstrated comparability in product quality, safety and efficacy.
Key figures
- Drug Name
- SIMLANDI (adalimumab-ryvk)
- Process name
- Process 2.0
- Output improvement
- more than doubles drug substance output per batch
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