For more than three decades, generic medicines have been one of healthcare's greatest success stories, helping hundreds of millions of people access affordable treatment while saving trillions of dollars worldwide. Yet a new study suggests that the same revolution has largely bypassed some of today's most important medicines for cancer, diabetes and autoimmune diseases, leaving patients and healthcare systems facing soaring costs.

Researchers at the University of California, San Francisco (UCSF), have found that differing regulations across 19 countries are slowing the development and approval of biosimilars — lower-cost versions of complex biological medicines. The findings were published on May 31 in JAMA Health Forum.

Unlike traditional medicines made from chemical ingredients, biologics are produced inside living cells. A biologic is more akin to growing a tree than a conventional medication, which is like building a brick using a predetermined recipe. That makes it far harder to create an exact copy. Instead, manufacturers produce biosimilars, which are highly similar versions proven to work just as safely and effectively.

The stakes are enormous.

“Just 5% of prescriptions are for biologics like Ozempic, but they make up more than half of all drug spending,” said Jonathan Watanabe, PharmD, MS, PhD, chair of the UCSF Department of Clinical Pharmacy and first author of the study. “Yet many countries aren’t equipped to quickly vet and approve of new biosimilars, limiting access for patients.”

The researchers examined regulatory frameworks in countries including the United States, Canada, the UK, Brazil, Egypt, Indonesia, and Nigeria. While most nations initially adopted similar definitions for biosimilars, their approval systems later diverged in significant ways.

Some regulators accept strong laboratory evidence showing that a biosimilar closely matches the original medicine. Others demand additional clinical studies involving patients, a process that can add years and millions of dollars to development costs. Several countries also insist on repeating studies locally even when trusted foreign regulators have already reviewed the evidence.

Differences extend to pharmacy counters. In some nations, pharmacists can substitute a biosimilar for a brand-name biologic much like they do with generic medicines. Elsewhere, doctors must issue a new prescription, creating another hurdle for patients seeking lower-cost treatment.

Health economists have long argued that competition drives prices down. Generic medicines transformed the market for blood pressure drugs, antibiotics, and painkillers. However, many blockbuster biologics used to treat cancer, autoimmune disorders, and diabetes continue to command premium prices, even though biosimilar alternatives are available.

The UCSF researchers believe greater international alignment could speed approvals, reduce duplication and improve accessibility. “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.

As demand for high-cost biologic medicines continues to rise worldwide, the study raises a pressing question: whether patients should continue paying premium prices because governments cannot agree on a common pathway for approving safe and effective lower-cost alternatives. For more than three decades, generic medicines have been one of healthcare's greatest success stories, helping hundreds of millions of people access affordable treatment while saving trillions of dollars worldwide. Yet a new study suggests that the same revolution has largely bypassed some of today's most important medicines for cancer, diabetes and autoimmune diseases, leaving patients and healthcare systems facing soaring costs.

Researchers at the University of California, San Francisco (UCSF), have found that differing regulations across 19 countries are slowing the development and approval of biosimilars — lower-cost versions of complex biological medicines. The findings were published on May 31 in JAMA Health Forum.

Unlike traditional medicines made from chemical ingredients, biologics are produced inside living cells. A biologic is more akin to growing a tree than a conventional medication, which is like building a brick using a predetermined recipe. That makes it far harder to create an exact copy. Instead, manufacturers produce biosimilars, which are highly similar versions proven to work just as safely and effectively.

The stakes are enormous.

“Just 5% of prescriptions are for biologics like Ozempic, but they make up more than half of all drug spending,” said Jonathan Watanabe, PharmD, MS, PhD, chair of the UCSF Department of Clinical Pharmacy and first author of the study. “Yet many countries aren’t equipped to quickly vet and approve of new biosimilars, limiting access for patients.”

The researchers examined regulatory frameworks in countries including the United States, Canada, the UK, Brazil, Egypt, Indonesia, and Nigeria. While most nations initially adopted similar definitions for biosimilars, their approval systems later diverged in significant ways.

Some regulators accept strong laboratory evidence showing that a biosimilar closely matches the original medicine. Others demand additional clinical studies involving patients, a process that can add years and millions of dollars to development costs. Several countries also insist on repeating studies locally even when trusted foreign regulators have already reviewed the evidence.

Differences extend to pharmacy counters. In some nations, pharmacists can substitute a biosimilar for a brand-name biologic much like they do with generic medicines. Elsewhere, doctors must issue a new prescription, creating another hurdle for patients seeking lower-cost treatment.

Health economists have long argued that competition drives prices down. Generic medicines transformed the market for blood pressure drugs, antibiotics, and painkillers. However, many blockbuster biologics used to treat cancer, autoimmune disorders, and diabetes continue to command premium prices, even though biosimilar alternatives are available.

The UCSF researchers believe greater international alignment could speed approvals, reduce duplication and improve accessibility. “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.

As demand for high-cost biologic medicines continues to rise worldwide, the study raises a pressing question: whether patients should continue paying premium prices because governments cannot agree on a common pathway for approving safe and effective lower-cost alternatives.