One of the first things I learned during my time at the FDA was that biology rarely cooperates with political talking points. That's not a criticism. It's simply reality.
Biological medicines are complicated. Patients are complicated. Scientific evidence is often complicated. Anyone looking for simple answers is usually asking the wrong question. Which is why I find the current effort to "genericize" biosimilars so troubling.
Supporters of the Biosimilar Red Tape Elimination Act and similar proposals insist they are merely eliminating unnecessary red tape. Their argument sounds straightforward: if a biosimilar has been approved by FDA, why shouldn't it automatically be deemed interchangeable and available for pharmacy-level substitution? It's an appealing sound bite. It is also a remarkably poor way to make healthcare policy.
What strikes me most about this debate is how casually some people now dismiss distinctions that regulators around the world spent decades establishing. The FDA says biosimilars are not generics. The European Medicines Agency says biosimilars are not generics. Health Canada says biosimilars are not generics.
The World Health Organization says the generic-drug model is not appropriate for biosimilars. Australia agrees. Japan agrees. Brazil agrees. Yet somehow Washington has convinced itself that the real problem is that everyone else has been overthinking it.
That's a bold position. It's also an odd one.
When virtually every major regulatory authority in the world reaches the same scientific conclusion, the burden of proof should fall on those seeking to overturn it—not on those defending it. What makes this particularly frustrating is that many of the arguments driving the current debate are built on a false premise.
We're told that FDA imposes rigid, burdensome requirements for interchangeable biosimilars. We're told that switching studies are essentially mandatory. We're told that scientific caution is preventing competition. None of these claims accurately describes the current system.
In reality, FDA already exercises considerable flexibility. The agency evaluates products individually. In some cases, it has required additional data. In others, it has not. Numerous interchangeable biosimilars have already been approved without switching studies. That isn't bureaucracy. That's scientific judgment. And there is a difference.
During my years at FDA, I never sat through a meeting where scientists argued that Congress should simply legislate the answer to a scientific question. The entire purpose of regulatory review was to determine whether the available evidence supported a conclusion. Sometimes the answer was yes. Sometimes it was no. Sometimes it was "we need more data."
What nobody suggested was eliminating the question altogether. Yet that is increasingly where this debate seems headed. If FDA already possesses the authority to waive studies when science supports doing so—and it does—then why is Congress being asked to remove FDA's discretion entirely? That's the question supporters of these proposals rarely answer. Perhaps because the answer has very little to do with science.
The real barriers to biosimilar uptake are not sitting inside FDA headquarters in White Oak, Maryland. They are sitting inside formulary committees. They are embedded in rebate agreements. They are reflected in contracting arrangements that determine which products patients can access and which products never gain meaningful market share.
Congress knows this.
Congressional committees have spent years investigating the role of pharmacy benefit managers and the market distortions they create. Yet instead of addressing those issues directly, lawmakers are being encouraged to weaken a scientific determination that wasn't causing the problem in the first place. That's a curious policy choice. Actually, it's worse than that. It risks solving the wrong problem while creating a new one.
The success of biosimilars in the United States did not happen because physicians abandoned scientific standards. It happened because they gained confidence in them.
Trust matters. Physicians trust biosimilars because they trust the review process behind them. Patients trust biosimilars because they trust their physicians. Undermine confidence in the process and you inevitably undermine confidence in the products. That's not speculation. It's human nature.
Another argument frequently advanced by advocates of "genericization" is that Europe has already moved in this direction. Having heard this claim repeated for years, I have become increasingly convinced that many people invoking Europe have not actually looked very carefully at what Europe does. European physicians routinely prescribe biosimilars. So do American physicians. But pharmacy-level substitution remains limited, uncommon, or restricted in many European countries. Europe did not create a generic-style automatic substitution framework for biologics. Yet that experience is repeatedly cited as justification for creating one here.
At some point, we should stop calling that harmonization and start calling it what it is: selective storytelling. None of this means biosimilar regulation should never evolve.
Science evolves. Analytical tools improve. Regulatory frameworks should adapt when evidence warrants adaptation. But there is a profound difference between refining scientific standards and pretending scientific distinctions no longer exist. The former is how regulatory science advances. The latter is how political narratives advance.
As a former FDA official, I remain deeply skeptical whenever elected officials or industry stakeholders insist that scientific questions have become so obvious that scientific review is no longer necessary. That's usually the moment when scientific review becomes most important.
The biosimilar marketplace is growing. Competition is increasing. Confidence is expanding. The system is not perfect, but it is working. Congress should focus its attention on the actual barriers to competition and affordability. It should leave the scientific determinations to the scientists. Because biology has not changed. And Congress has not discovered a way to legislate around it.
Peter J. Pitts is a former FDA Associate Commissioner and President of the Center for Medicine in the Public Interest.
