Recent analyses have found that the U.S. is lagging behind Europe in the use of biosimilar versions of branded biologic drugs, but the U.S. Food and Drug Administration (FDA) contends that its biosimilars approval rate is not as far behind that of the European Medicines Agency (EMA) as critics suggest.
Leah Christl, PhD, associate director for therapeutic biologics at the FDA’s Center for Drug Evaluation and Research, told STAT News that several biosimilars approved by the EMA aren’t considered biosimilars under the FDA’s definition, and many are available in the U.S. under a different pathway.
She also said the FDA plans to finalize guidance on the interchangeability of biosimilar drugs by May 2019. If the agency designates a biosimilar as interchangeable with a biologic, pharmacists can distribute the drug without consulting the prescribing doctor. None of the nine biosimilars on the market has been designated interchangeable with the reference biologic.
Source: STAT News, April 17, 2018.