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The Food and Drug Administration 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.


She said several of the biosimilars included on the EMA list aren’t considered biosimilars under the FDA’s definition — and many of those drugs are available in the U.S., but under a different pathway. The European agency also separately counts drugs marketed under different trade names, while the FDA does not. The EMA has also been approving biosimilars since 2006, while the FDA approved its first in 2017.

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