Alvotech Shares Jump Premarket After FDA Approves New Manufacturing Process for Simlandi

3-line summary

• Biosimilar maker Alvotech said the FDA approved a new manufacturing process, "Process 2.0," for producing the adalimumab (Humira biosimilar Simlandi) drug substance at its DSM2 facility in Reykjavik, Iceland; the company said the process more than doubles drug-substance output per batch without changing upstream production scale, and demonstrated comparability to the existing approved process with quality, safety, and efficacy maintained.
• Alvotech COO Joseph McClellan said "the new process allows us to manufacture the same quantity of drug substance in fewer batches," freeing up capacity that can be redirected to other products in the company's portfolio, which includes five approved biosimilars sold in multiple countries: Humira, Stelara, Simponi, Eylea, and Prolia/Xgeva.
• Shares rose more than 6% in premarket trading Tuesday; the approval follows a recent FDA capacity approval and gives the company more flexibility to respond to demand increases.

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