Over the past six months, numerous pharmaceutical companies have announced plans to invest in new U.S. manufacturing facilities within the next decade. This so-called “onshoring,” motivated by the Trump administration’s announcement of sector-specific tariffs, appears to strengthen domestic manufacturing capabilities and mitigate potential risks of supply disruption. However, the lengthy timeline required to establish new manufacturing facilities raises concerns. To expedite this process, the president signed an order to accelerate FDA approval for domestic drug manufacturing plants while increasing fees and inspections for foreign facilities.
These initiatives aim to “put America first,” yet the political imperative may be more effectively achieved through fostering healthy market competition. Such an approach could yield both short- and long-term benefits for all stakeholders, especially patients. The sustainability of biosimilars is at stake, as companies like Samsung Bioepis strive to make these essential biologic medicines more accessible. Without a focus on commercial viability, the critical window for advancing biosimilars may close, jeopardizing the progress made in this vital sector.
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