FDA issues draft guidance on biosimilar interchangeability

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FDA issues draft guidance on biosimilar interchangeability

By David Salazar - 01/17/2017

SILVER SPRING, Md. — The Food and Drug Administration recently shared the first draft guidance addressing the interchangeability of biosimilar drugs and their reference products. 


The draft guidance outlines that to sufficiently demonstrate interchangeability, the proposed interchangeable product has to be biosimilar and expected to produce the same clinical results as the reference product on any given patients. And interchangeable products that will be administered more than once should have data showing that switching a patient between the biosimilar and the reference product poses no greater risk than the reference product being used continuously does. 


“FDA’s high standards for approval should also assure healthcare professionals that they can be confident in the safety and effectiveness of an interchangeable product, just as they would be for a reference product,” Leah Christi, the FDA’s associate director for therapeutic biologics and lead of the Office of New Drugs’s therapeutic biologics and biosimilars staff wrote in a “From our perspective” post on the FDA’s website. “The availability of biosimilar and interchangeable products in the U.S. marketplace will provide more treatment options, which will hopefully drive down costs to give more patients access to treatment.”


Christi also notes that once a product is approved as interchangeable, it can be substituted without intervention from a prescriber. 


The publication of the draft guidance means that stakeholders can now comment for 60 days after Jan. 18, the day the guidance gets published in the federal register in order for comments to be considered before the final version of the guidance is written. The FDA has promised a finalized guidance on interchangeability before the end of the year.