Investing.com -- Alvotech shares rose more than 6% in premarket trading Tuesday after the U.S. Food and Drug Administration approved a new manufacturing process for Simlandi, the company's biosimilar to Humira.
The approval permits Alvotech to implement Process 2.0 for manufacturing adalimumab drug substance at its DSM2 facility in Reykjavik, Iceland. The new process more than doubles drug substance output per batch without changing the upstream manufacturing scale, according to the company.
Alvotech said the improvement was achieved through process development, transfer and validation, with demonstrated comparability to the previously approved process while maintaining product quality, safety and efficacy.
"The new process allows us to manufacture the same quantity of drug substance in fewer batches, freeing up capacity to support other products in our portfolio," said Joseph McClellan, Chief Operating Officer of Alvotech.
The company said the approval provides greater flexibility to respond to growing demand and follows a recent FDA approval of additional manufacturing capacity.
Alvotech is a biotechnology company focused on the development and manufacture of biosimilar medicines. The company has five biosimilars approved and marketed in multiple global markets, including biosimilars to Humira, Stelara, Simponi, Eylea and Prolia/Xgeva.
Original Article
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