Alvotech receives FDA approval for updated SIMLANDI manufacturing process
The U.S. FDA has approved a new manufacturing process for Alvotech’s biosimilar SIMLANDI, allowing for a more than twofold increase in output per batch.
Biotechnology company Alvotech has secured approval from the U.S. Food and Drug Administration (FDA) for an updated manufacturing process regarding its adalimumab biosimilar, SIMLANDI. The new process will be implemented at the company’s Reykjavik, Iceland facility and is designed to increase drug substance output per batch by more than 100% without expanding the current facility's physical footprint.
The update, referred to as Process 2.0, follows successful validation trials demonstrating that the modified production method maintains product quality, safety, and efficacy comparable to the previously approved process. By increasing yield, Alvotech expects to fulfill production requirements in fewer batches.
Alvotech Chief Operating Officer Joseph McClellan stated that the higher yield optimizes the company's existing infrastructure, allowing for increased flexibility and capacity to support other products within its portfolio. The move is intended to assist the firm in meeting rising demand for its biosimilar treatments across international markets.