Jonathan Watanabe and his colleagues at UC San Francisco identified a stubborn problem hiding in plain sight: the rules governing biosimilar drugs—affordable copies of blockbuster biologic medicines—differ wildly across 19 countries, slowing their approval and keeping them out of patients' hands.
Biologics like Ozempic represent one of modern medicine's greatest achievements. Yet they also represent a paradox. Though they account for just 5% of prescriptions worldwide, they consume more than half of all drug spending. Unlike traditional generic drugs, which are chemical copies of their brand-name predecessors and have saved trillions of dollars over 30 years, biosimilars are far trickier to manufacture. Biologics are massive, protein-sized molecules produced inside living cells—not simple chemicals mixed in a vat. Their biosimilar equivalents are close but not identical copies, which makes their regulation far more complex.
The UCSF research team, whose findings appear in JAMA Health Forum, examined biosimilar regulations across the United States, Canada, the United Kingdom, Nigeria, Brazil, Egypt, Indonesia, and 11 other nations. What they discovered was regulatory chaos dressed up as consistency. Most countries began with similar language to describe what a biosimilar actually is. But from there, their approval frameworks diverged sharply. Some nations were content to approve biosimilars if laboratory tests showed they were "similar enough" to the original drug. Others demanded rigorous patient trials. Some countries authorized pharmacists to swap a biosimilar for a biologic at the counter, no questions asked. Others required the prescribing doctor to explicitly approve or rewrite the prescription. And while some regulators were willing to accept data and studies conducted by trusted foreign agencies, others insisted companies repeat all trials locally—a costly and time-consuming redundancy.
"Many countries aren't equipped to quickly vet and approve new biosimilars, limiting access for patients," said Watanabe, chair of the UCSF Department of Clinical Pharmacy. The consequence is predictable: biosimilars take longer to reach market, stay more expensive, and remain unavailable in countries that might need them most.
The solution, according to the researchers, is elegant: harmonize biosimilar regulations across countries. If nations agreed on a streamlined approval process—one that recognized trusted foreign regulators, standardized laboratory and clinical testing requirements, and allowed flexible dispensing rules—biosimilars could enter the market faster and cheaper. It's a playbook that already works. Generic drugs transformed prescription affordability precisely because regulators like the FDA built a streamlined approval pathway that didn't require redundant testing of brand-name drugs already deemed safe and effective.
"Generics represent one of the biggest success stories of the pharmaceutical industry in terms of making life-extending treatments more affordable, and we hope our study helps biosimilars do the same," Watanabe said. The window is open. As patents expire on blockbuster biologics—expensive treatments for diabetes, cancer, and autoimmune disease—the race is on to move biosimilars through regulatory systems faster. Global alignment won't happen overnight, but the UCSF research makes the case irrefutable: the regulations exist. What's needed now is the will to align them.