By S. Ropka, Ph.D., T. Mathias, and R. Auroprem, Axinn, Veltrop & Harkrider LLP Most biosimilars (follow-on biologics products) still only have shares below 50% in the U.S., which is far different than market shares in Europe. One major reason is a mistrust around biosimilars’ safety and efficacy. Congress has stepped in to address that issue through the Advancing Education on Biosimilars Act of 2021, with the goal of encouraging rapid uptake soon after biosimilars become commercially available.
