BioRationality: Commemorating the 15th Anniversary of the BPCIA

The Biologics Price Competition and Innovation Act (BPCIA), enacted on March 23, 2010, was designed to create a regulatory pathway to approve highly similar biologics with no clinically meaningful differences in safety, purity, and potency from the reference product. Like the Hatch-Waxman Act of 1984 that paved the way for the approval of generic drugs, the BPCIA was enacted to promote competition, reduce health care costs, and increase access to biologic therapies after the exclusivity period of 12 years.

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Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars (OTBB) in CDER’s Office of New Drugs, states, “FDA uses comprehensive testing that compares a biosimilar’s structural and functional characteristics to the reference product to ensure the biosimilar is as safe and effective as the reference product without unnecessary duplication of human testing.” This is the most critical statement by the FDA. In my view, once thorough analytical characterization is complete, additional clinical testing often provides limited value, potentially leading to unnecessary resource use and ethical concerns around subjecting individuals to avoidable trials. It may be time for the FDA to consider publicly stating that further testing isn't needed in such cases—and to explore opportunities for issuing updated guidance under the BPCIA framework without waiting for Congressional action.

The BPCIA also helped expand the biologics industry by enabling new companies to enter the field. Still, this progress has been severely limited due to the high cost of developing biosimilars. This must change.

While the US biologics market has grown 12.5% annually over the last 5 years and is projected to grow to as much as 129 billion in sales by 2027,¹ it is not sufficient evidence of the success of biosimilars, as widely touted by stakeholders. Do we ever talk about how much savings is brought to us by generic drugs?

There are still issues to resolve, and one is the double patenting that was about to be removed, but the United States Patent and Trademark Office backed off at the last moment, creating a huge conflict of interest.

In my opinion, once the FDA has made a determination that 2 products are biosimilars, that designation should be sufficient to instill confidence in their safety and efficacy. While education is important, it may be more effective if led by the FDA, which holds the scientific authority and regulatory oversight. Streamlining messaging in this way could help avoid duplicative efforts and potential confusion among patients and prescribers.

The more we teach, the more we provide a chance for big pharma to bring up the topic and add to the confusion and distrust.

In my view, many stakeholders would benefit from a deeper understanding of how biosimilar policy and market forces interact. I've noticed some argue that if the Inflation Reduction Act lowers the price of reference biologics, it could reduce incentives to develop biosimilars. Personally, I find that logic unconvincing. If an innovator voluntarily reduces the price of a reference product, we generally celebrate it as a win for competition and patients—so why should a government-led reduction be viewed differently? To me, these kinds of misconceptions have only served to create more room for large pharmaceutical companies to resist efforts by the FDA and Congress aimed at expanding access to affordable biosimilars.

My note to the FDA is aimed at encouraging the agency to continue its mission, and I believe we are almost there. Good luck!

Reference

1. Jeremias S. IQVIA: US spending on biosimilars to reach $129 billion over next 5 years. The Center for Biosimilars^®. February 9, 2023. Accessed April 7, 2025. https://www.centerforbiosimilars.com/view/iqvia-us-spending-on-biosimilars-to-reach-129-billion-over-next-5-years