FDA Approves Alvotech Process Doubling SIMLANDI Production Output
Alvotech received FDA approval for a new manufacturing process that more than doubles the drug substance output per batch for its biosimilar medicine SIMLANDI.
The U.S. Food and Drug Administration approved a new manufacturing process, designated as Process 2.0, for Alvotech's biosimilar medicine SIMLANDI (adalimumab-ryvk). The updated process is implemented at the company's DSM2 manufacturing suite in Reykjavik, Iceland.
This technical improvement more than doubles the drug substance output per batch without increasing the upstream manufacturing scale. Alvotech achieved the increase through targeted process development and validation while maintaining the quality, safety, and efficacy of the product.
Chief Operating Officer Joseph McClellan stated that the achievement reflects the expertise of the company's process development and manufacturing teams. The new process allows Alvotech to manufacture the same quantity of drug substance in fewer batches, which increases capacity to support other products in its biosimilars portfolio and provides greater flexibility to respond to growing market demand.
