By Juliana M. Reed, April 30, 2025 | From: RealClearHealth

America’s skyrocketing prescription drug costs must be addressed. President Trump, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary, and other Administration leaders have committed to reign in burdensome bureaucracy and deliver America into a golden age of healthcare affordability, innovation, and access.

Fifteen years ago, Congress passed the landmark Biologics Price Competition and Innovation Act (BPCIA) to pave the way for biosimilars to lower drug costs for Americans. Biosimilars are safe, effective, and lower-cost versions of biologic drugs that treat cancer, diabetes, psoriasis, arthritis, eye disease, and more illnesses.

Since the first biosimilar was approved in 2015 by the FDA, more than 70 biosimilars have been approved and saved the U.S. healthcare system $56 billion, with the potential to save an additional $189 billion in the next five years. Biosimilars also generate billions in cost-savings in the Medicare program as prices continue to increase for reference biologic drugs. In fact, these medications were 46% of U.S. prescription drug spending in 2022, despite only making up 3% of prescriptions. Americans spent $568 billion on pharmaceuticals in 2022 with $260 billion going toward biologics.

Unfortunately, the American healthcare system faces a major void of biosimilars in the pipeline. Of the 118 biologics set to lose patent protection in the next decade, only 10% have biosimilars in development. This biosimilar void threatens to leave patients without affordable alternatives, forcing them to rely on high-cost brand-name drugs.

Regrettably, the FDA has not been able to evolve as it gains greater experience approving biosimilars. While the science that guides biosimilar development has advanced, the FDA has been slow to change because of bureaucracy inside the agency. The FDA biosimilar team has been forced to follow outdated, inefficient, and scientifically-unnecessary requirements that delay patient access to critical medicines. With support from the Administration, the FDA biosimilars team can create a more efficient scientific review process for biosimilars.

The FDA can modernize the development of safe and effective biosimilars to increase efficiency and eliminate unnecessary bureaucracy simply by following the science.

After 15 years of biosimilar development and review by the Office of Therapeutic Biologics and Biosimilars (OTBB), the FDA should enhance OTBB’s authority within the agency. OTBB personnel are medical experts who understand the science of biosimilar development. They created the biosimilar industry in the U.S. from the ground up. They designed incredibly efficient new processes to reflect scientific advances. Without them, biosimilars in the U.S. would not exist.

The FDA should provide OTBB with signatory approval on biosimilar reviews and applications to refocus the agency’s resources in the clinical review process for new, innovative medicines.  OTBB should also continue to consult with a clinical reviewer when needed, but not on a routine basis. This will allow FDA to increase efficiency and reflects the current science of biosimilar development which is built on a decade of FDA approvals, lab analytical comparison data, and other publicly available research prove this point.

The Biosimilars Forum recently submitted a Citizen Petition to the FDA recommending that the FDA should eliminate regulatory hurdles like their request for routine 3-way pharmacokinetic (“PK”) studies that compare U.S. and non-U.S. versions of a drug.

Another simple step the FDA can take is to eliminate the biosimilar ‘suffix.’ Our analysis demonstrates that the suffix adds no value and is not used in reporting.

With the Administration’s focus on efficiency and having the right resources in the right place, the FDA should not let outdated bureaucratic processes deprive Americans of medicines they need. Simple FDA process updates will increase biosimilar development and create free market competition. Outdated, scientifically-unjustified bureaucratic regulations stifle the development of innovative, lower-cost medicines, including biosimilars. It’s time to change.