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NOVEMBER 15, 2024

Pros and Cons to Updating Biosimilar Switching Guidance


Originally published by our sister publication Specialty Pharmacy Continuum

By Myles Starr

This summer, the FDA proposed removing the requirement that biosimilar drug manufacturers submit clinical switching studies to demonstrate interchangeability between their product and a brand-name reference drug. This move, which aims to boost competition between manufacturers and bring down costs for patients, drew support from the Federal Trade Commission. 

Under new proposed guidelines, in lieu of a