Fresenius Kabi has described the latest query over its pending application for a US biosimilar to Actemra (tocilizumab) as a “broken record in every call,” after the German firm earlier this year received a setback in its target to be the first mover in the US.
“As I said last time, we’re working with the US Food and Drug Administration, we handed in all papers within the process of interacting with the regulatory body. No hiccups. Everything has been filed from our side