Under the agreement announced on October 6, LOTTE Biologics will manufacture drug substance for several of Alvotech’s antibody biosimilars at its facility in Syracuse, New York, which has 40,000 liters of bioreactor capacity. The site recently passed an FDA inspection with zero observations. Commercial supply depends on successful technology transfer, manufacturing qualification and the necessary regulatory approvals.

On October 5, the FDA approved a supplement to the Biologics License Application for SIMLANDI (AVT02). It allows drug substance manufacturing in Alvotech’s second production suite, DSM2, in Reykjavik. According to the company, this doubles the drug substance capacity available for US supply of the product.

“We will have sufficient capacity to meet demand for our pipeline for the next ten years,” said CEO Lisa Graver.