Posted by Michael Wonder on 18 Apr 2018
FDA official insists U.S. is catching up to Europe on biosimilar regulations, approvals
17 April 2018 - The FDA lags behind its European counterpart when it comes to approving biosimilars — but a top agency official insisted Tuesday that the agency is not as far behind as some critics suggest.
Leah Christl, the associate director for therapeutic biologics at the FDA’s Center for Drug Evaluation and Research, pushed back on an oft-cited statistic that shows the European Medicines Agency has so far approved more than 40 biosimilars, drugs that are almost identical to biologics, compared to just nine approved in the U.S. by the FDA.
