With the April approval of trastuzumab-strf (Hercessi, Accord BioPharma), a HER2/neu receptor antagonist that is a biosimilar for Herceptin (Genentech)—the FDA marked its approval of 50 biosimilar agents. 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.
“The [updated] BAP describes the agency’s high-level vision to encourage