FDA approves Alvotech's Simlandi manufacturing process that more than doubles output per batch
ALVO•The FDA approved Alvotech's new manufacturing process for Simlandi, which more than doubles drug substance output per batch at its Reykjavik facility without increasing upstream manufacturing scale.
1. Higher batch output
The FDA approved Alvotech's new manufacturing process for Simlandi, its biosimilar to Humira. The process more than doubles drug substance output per batch at the company's Reykjavik facility without increasing upstream manufacturing scale. Producing the same quantity in fewer batches frees capacity for other biosimilars while maintaining product quality, safety and efficacy.
