Assessing Generic & Biosimilar Manufacturing in North America & the Potential Opportunity for the CaliBaja Region – Report 2024

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In recent years, the United States has experienced shortages of many essential medicines, putting at risk the stability of its healthcare systems and ability to meet the priority health care needs of its population. Over 90% of medicines consumed by Americans are generic drugs and biosimilars.

The U.S. has become over-reliant on lower cost overseas sources, principally from China and India, for much of the active pharmaceutical ingredients (APIs) and key starting materials (KSMs) required to make many generic and essential drugs. While the United States is a world leader in developing and marketing patented branded prescription drugs, a significant portion of America’s generic drugs are sourced from overseas, with a large percentage also coming from China and India. This dependence poses supply chain risks and national security concerns.

As the United States looks to strengthen and make its pharmaceutical supply chain more resilient, the CaliBaja region could play a valuable role given San Diego’s strong life science ecosystem and Baja California’s lower cost of manufacturing and talented STEM labor force.  

The Institute’s report and July 16th forum explore current and emerging North American essential medicine needs, examine emerging opportunities for future generic and biosimilar manufacturing in Mexico with special emphasis on Baja California and its potential cross-border nexus with San Diego over the coming years.

The Assessing Generic & Biosimilar Manufacturing Report has been made possible thanks to the generosity of Malin Burnham and the Burnham Foundation; the Alumbra Innovations Foundation, Steve Williams, and Bill Koman.