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JULY 19, 2024

FDA Updates Biosimilars Action Plan


Originally published by our sister publication Specialty Pharmacy Continuum

By Myles Starr

With the April approval of Hercessi (trastuzumab-strf, Accord BioPharma)—a HER2/neu receptor antagonist that is a biosimilar for Herceptin (trastuzumab, Genentech)—the FDA marked its 50th biosimilar agent. At the same time, the agency also updated its Biosimilars Action Plan (BAP) (first released in 2018) to reinforce its strategy to further expand biosimilar product availability and use.