News Briefs: Sen. Mike Lee Introduced Biosimilar Red Tape Elimination Act

Sen. Mike Lee (R-Utah) unveiled legislation aimed at boosting competition among biologics and reducing consumer costs for the agents. Introduced on Nov. 17, the Biosimilar Red Tape Elimination Act (S.6) would do away with the FDA requirement for switching studies for biosimilars seeking the interchangeability designation. “Eliminating this barrier would increase access to lower-cost biosimilars and save payers and consumers billions over the next five years,” according to a press release from Lee’s office. In contrast to the European Union, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) recently clarified that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars. Also quoted in the release was Sarfaraz Niazi, Ph.D., an adjunct professor of biopharmaceutical ciences at the College of Pharmacy at the University of Illinois Chicago, who pointed out that “according to the FDA, ‘biosimilars have no clinically meaningful difference with their reference product,’ so if there is no difference, they should be interchangeable without the extensive and expensive switching and alternating studies in patients.”

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