Onshoring and Its Impact on Biosimilars and Generics
Supply chain disruptions with biosimilars will threaten the entire biologics ecosystem, according to a Samsung Bioepis VP and head of regulatory strategy and policy.
Recently, numerous pharmaceutical companies have announced plans to invest in new U.S. manufacturing facilities within the next decade, a trend known as "onshoring." This move is motivated by the Trump administration's announcement of sector-specific tariffs, aiming to strengthen domestic manufacturing capabilities and mitigate potential risks of supply disruption.
The president signed a separate order to hasten the FDA approval process for domestic drug manufacturing plants, while simultaneously increasing fees and inspections for foreign facilities.
These initiatives aim to "put America first," but may be achieved more efficiently with less drastic measures, as the years of time it takes to build a new manufacturing facility could be shortened.
Author's summary: Onshoring may disrupt biosimilars supply chain.