Case Study: a pharmaceutical company achieves first-cycle USFDA approval for a biosimilar with Freyr

Pharmaceutical Company secures first-cycle USFDA approval with FREYR after 4X impurity study

FREYR supported a pharmaceutical company facing a significant regulatory challenge. The client was developing a biosimilar but its product, made with a eukaryotic expression system, contained glycosylated impurities not found in the innovator's prokaryotic version, jeopardizing U.S. FDA approval.

FREYR implemented a dual strategy to resolve this. They first conducted an animal safety study using a high concentration of the impurities and secondly added a purification step to reduce impurity levels. By presenting this data to the FDA, FREYR enabled the pharmaceutical company to mitigate the regulatory risks, ensuring compliance and securing a seamless first-cycle approval for the biosimilar.