U.S. Generic Drugs, Biosimilars Construction Queues Up as Trump Plans for Generics Tariffs

---

Written by Eric Funderburk for IIR News Intelligence (Sugar Land, Texas)

---

Summary

This week, U.S. President Donald Trump proposed the implementation of tariffs of 200% on generic drugs by 2029, presumably giving time for companies to build U.S. manufacturing sites before the tariffs reach their peak in a couple of years.

---

Generic Drug Tariffs

In a week filled with tariff news, U.S. President Donald Trump last week implemented plans to begin phasing in a 200% tariff on generic drugs imported into the U.S. Generic drugs and their biological-drug counterpart, biosimilars, were specifically exempted from this year's Section 232 tariff policies, although patented medicines face a 100% tariff.

However, generic drugs are now on Trump's tariff radar. The president's plan calls for two years of tariff-free generics starting August 1 this year. In August 2028, a 100% tariff would be implemented on generic drugs, which would increase to 200% in 2029, after Trump's second term has ended. The industry is seeking clarity on whether biosimilars are included in this tariff scheme.

Industrial Info Resources data indicate hundreds of millions of dollars' worth of U.S. construction aimed at manufacturing generic drugs that is already underway or on the horizon, and this could very well increase if companies decide to escape the planned 200% import tax by growing their U.S. footprint.

U.S. Generic Drugs Construction

Several generics-targeted construction projects are underway in the U.S., and Industrial Info Resources is tracking many more in the planning and engineering stages. One of the largest on-the-ground projects comes from drug manufacturer American Regent, which develops both branded and generics drugs, primarily injectables, for a range of conditions from anemia to animal joint care to oncology drugs. The company is underway with a major expansion of its plant in New Albany, Ohio, by adding multiple stories to three buildings and constructing a new building targeting its latest oncology products.

According to Industrial Info Resources data, most of the current generics construction in the U.S. is for expansions at existing plants as well as the repurposing of existing infrastructure at brownfield sites. One of these brownfield projects is underway in Verona, Wisconsin, from contract development and manufacturing organization (CDMO) ANI Pharmaceuticals, which is repurposing a 27,000-square-foot facility to manufacture primarily generic parenterals (avoiding the gastrointestinal tract) in both injectable and tablet forms.

Several other construction projects targeting generic drugs in one form are another are underway, and many more loom on the horizon, although the ultimate fate of these planned projects can be uncertain. Particular hotspots for future generics construction include Ohio, where American Regent already is planning another building addition at its New Albany plant and Hikma Pharmaceuticals will perform additions to its Bedford plant in order to grow its services involving contract filling and lyophilization, a form of freeze-drying used for drug stabilization.

Biosimilars

Far fewer U.S. projects specifically targeting biosimilars are seen, as the very nature of these drugs is to escape high research, development and manufacturing costs in order to develop and manufacture less expensive but still effective biosimilars that are outside patent protection. Industrial Info's coverage of plants specifically aimed at biosimilars presently shows the strongest construction markets outside of the U.S., but this could shift as biosimilars' status under the recent tariff announcements becomes clearer.

One notable biosimilars player both in the U.S. and abroad is CDMO Samsung Biologics. In December last year, the company announced it would acquire Human Genome Sciences from GSK, giving Samsung Biologics its first U.S. manufacturing site in Rockville, Maryland. The company has announced plans to increase its U.S. production capacity, although with its just-acquired manufacturing presence on U.S. soil, those plans remain somewhat tentative and could target the Rockville or elsewhere. As a side note, Rockville itself is a pharma-biotech hotspot, accounting for no less than 36 pharma-biotech facilities being tracked by Industrial Info Resources in the immediate area.

Samsung Biologics already is a leading global biosimilars CDMO organization and is behind one of the largest biosimilars construction projects anywhere in the world: a US$1.3 grassroot billion+ injectable fill- and- finish plant in its home country of South Korea, which is expected to break ground later this year.

While that particular project puts South Korea in a leading position for biosimilars construction, a country worth noting for its current activity is Slovenia, where two substantial biosimilars construction projects are underway--one a grassroot aseptic fill- and- finish plant and the other the expansion of an existing plant in Lendava, headed by leading drug manufacturer Sandoz Group.

Key Takeaways

• President Donald Trump has outlined a plan that would step up tariffs on generic drugs imported into the U.S. to 200% in 2029.
• Industry players remain uncertain if new proposal encompasses biosimilars, which along with generic drugs were specifically exempted from Section 232 tariffs in April this year.
• Samsung Biologics is one of the world's leading biosimilars players, recently acquiring its first U.S. manufacturing plant, and plans to invest more than US$1.3 billion in a grassroot fill- and- finish plant in South Korea.

---

About Industrial Info Resources
Industrial Info Resources (IIR) is the leading provider of industrial market intelligence. Since 1983, IIR has provided comprehensive research, news and analysis on the industrial process, manufacturing and energy related industries. IIR's Global Market Intelligence (GMI) helps companies identify and pursue trends across multiple markets with access to real, qualified and validated plant and project opportunities. Across the world, Industrial Info Resources is tracking over 250,000 current and future projects worth $30.2 trillion (USD).