Nine out of 10 prescriptions are filled with generic drugs, FDA-approved carbon copies of brand-name drugs whose patents have expired. Over the past 30 years, generic drugs have saved hundreds of millions of people trillions of dollars.
However, new biologic medicines, including breakthrough treatments for diabetes, cancer, and autoimmune diseases, are difficult to manufacture as generic drugs. Unlike traditional “small molecule” drugs made from chemicals, biologics are large protein-sized molecules made in living cells. Their equivalents, called biosimilars, are similar but not identical copies.
Now, a study by researchers at the University of California, San Francisco shows that regulations for biosimilars vary around the world, slowing their development and adoption.
“Biologics like Ozempic make up only 5% of prescriptions, but they account for more than half of all drug spending,” said Jonathan Watanabe, PharmD, MS, PhD, chair of the UCSF Department of Clinical Pharmacy and lead author of the paper. JAMA Health Forum “However, many countries do not have the capacity to rapidly review and approve new biosimilars, limiting patient access.”
Generic drugs have revolutionized the prescription drug market in large part because regulatory agencies such as the U.S. Food and Drug Administration (FDA) rely on their records when approving branded drugs. However, biosimilars can be different from the original biologic and do not offer the same streamlined process.
Watanabe and his colleagues conducted a detailed study of biosimilar regulations in 19 countries, including the United States, Canada, the United Kingdom, Nigeria, Brazil, Egypt, and Indonesia. Most countries initially used similar wording for biosimilars, but approval rules quickly differed.
Some countries had no problem approving biosimilars if they were “sufficiently similar” to biologics in clinical tests, but others required further testing in patients. Some pharmacists allowed the use of biosimilars in place of biologics at the pharmacy counter, while others required prescribing physician approval or a new prescription. Some companies were also willing to use data and findings from trusted foreign regulators, while others required companies to repeat the investigation locally.
Coordinating biosimilar approvals across countries could make it easier to bring biosimilars to market and reduce costs for all patients, similar to generic drugs, researchers say.
Generic medicines are one of the pharmaceutical industry’s greatest success stories in making life-sustaining treatments more affordable, and we hope our research will have a similar effect with biosimilars. ”
Jonathan Watanabe, PharmD, M.A., Ph.D., UCSF Department of Clinical Pharmacy Chair, first author of the paper
sauce:
University of California, San Francisco
Reference magazines:
Watanabe JH others. (2026) Regulatory definitions and classification of biosimilar medicines across six World Health Organization regions: a scoping review. JAMA Health Forum. DOI: 10.1001/jamahealthforum.2026.1642. https://jamanetwork.com/journals/jama-health-forum/fullarticle/2849727
