Biologic medicines have revolutionized healthcare, offering life-saving treatments. However, despite being only 2% of all prescriptions, brand biologics now account for nearly half of U.S. drug spending. Fortunately, we can deliver the same powerful treatment for a fraction of the expense. Biosimilars—lower-cost versions of biologics—have already saved the healthcare system around $36 billion since their introduction in 2015.
Yet, despite these successes, biosimilars face relentless waves of misinformation from brand-name manufacturers, particularly when it comes to the concept of “interchangeability.” Under current U.S. law, manufacturers can seek an additional “interchangeability” designation from the FDA, but this process is costly and doesn’t necessarily mean that more patients get the product. Importantly, the FDA itself has stated there is no scientific difference between biosimilars and interchangeable biologics. Countries like Japan and those in the European Union treat all approved biosimilars as interchangeable from the outset.
Now, Congress is considering the bipartisan Biosimilar Red Tape Elimination Act (BRTEA), which would streamline the regulatory process by removing the unnecessary distinction between biosimilars and interchangeable biologics. This common-sense proposal follows the FDA’s recommendation to treat all biosimilars as interchangeable, eliminating redundant regulatory barriers.
Unsurprisingly, this proposal has provoked a new round of misleading attacks from PhRMA, the lobbying arm of major brand drug companies like Amgen and J&J. Let’s break down why their claims don’t hold water.
Claim: Eliminating the interchangeability designation would weaken scientific standards.
Fact Check: FALSE ✗.
PhRMA argues that doing away with the interchangeability designation would tie the FDA’s hands by preventing it from requiring switching studies when necessary. In reality, the Biosimilar Red Tape Elimination Act maintains the FDA’s authority to require switching studies on a case-by-case basis. The bill specifically directs the FDA to update or revise guidance on the data needed to support biosimilar approvals, including switching studies “if appropriate.” For more complex biologics, the FDA will still have the flexibility to request additional data.
The FDA itself has expressed support for this legislative approach, stating that it aligns with current scientific understanding and global regulatory practices. In Europe, for example, biosimilars are automatically considered interchangeable upon approval. By removing the unnecessary bureaucratic step of interchangeability, the BRTEA would foster greater competition and increase patient access to lower-cost treatments—exactly the opposite of what PhRMA claims.
Claim: The legislation doesn’t address the broader issue of pharmacy benefit managers (PBMs) blocking biosimilar competition.
Fact Check: TRUE ✓—But That’s Not the Point.
It’s true that the BRTEA doesn’t address the PBM practices that often favor high-priced brand drugs over biosimilars. However, that’s not the goal of this legislation. Other bills are in the works to tackle PBM abuses, such as bipartisan legislation that would require PBMs to provide preferred formulary coverage to biosimilars when their price is less than a brand. One is compelled to ask if PhRMA’s support for biosimilars extends to such proposals.
Rather, the misinformation on biosimilars is an obvious attempt to distract from the fact that the real problem often lies with brand manufacturers themselves. For instance, the maker of Humira struck rebate deals with PBMs to block biosimilar access, despite the lower costs of those alternatives. The brand manufacturers have played a key role in distorting the system, and while PBM reforms are crucial, they are a separate issue from what the BRTEA addresses.
Claim: The bill would create more opportunities for “greedy middlemen.”
Fact Check: FALSE ✗.
PhRMA itself admits that the bill doesn’t deal with PBMs, so the claim that it would somehow empower them is nonsensical. In fact, by eliminating the unnecessary interchangeability designation, the BRTEA would lower development costs and increase competition, putting more pressure on PBMs to cover biosimilars sooner.
The Bottom Line:
The Biosimilar Red Tape Elimination Act is a bipartisan, science-backed proposal aimed at increasing competition and lowering drug prices. By removing the needless distinction between biosimilars and interchangeable biologics, it would align U.S. regulatory standards with those of other major markets like Europe. As the FDA has noted, this move would promote biosimilar uptake, ultimately driving down costs and expanding access to life-saving medications.
The facts are clear: biosimilars are safe, effective, and critical to making healthcare more affordable. It’s time to cut through the brand-manufacturer noise and support legislation that prioritizes patients over profits.
