Interchangeable biosimilars will hit market within 2 years, says FDA leader

The Food and Drug Administration has approved five biosimilars since 2010 — none of which are designated as "interchangeable" to the biologic drug they mimic, reports Regulatory Focus.

The FDA defines an interchangeable biosimilar as a comparable version of a biologic that "can be expected to produce the same clinical result as the reference product in any given patient."

In Europe, all biosimilars are considered interchangeable. However, in the U.S., only designated interchangeable biosimilars can be swapped with the reference product without a physician specifically requesting the substitution, according to Regulatory Focus.

Leah Christl, the FDA's associate head of biosimilars, commented on the future of interchangeable biosimilars at the Drug Information Association's annual conference in Chicago last week. She expects interchangeable biosimilars to enter the market within two years, according to the report.

Nine drug companies have publically disclosed submitting 14 applications for interchangeable biosimilars to the agency for regulatory review, according to Ms. Christl.

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