Medicines derived from living cells — biologics — are some of the most expensive medicines in America. What keeps prices sky-high isn’t the science — they are complex drugs — it’s the bureaucracy. Unlike in other countries, lower-cost biosimilars are blocked from the market by byzantine regulations that prevent pharmacists from substituting them like traditional generic medicines. The result has been artificially inflated drug prices, limited competition, and billions in avoidable costs for patients and insurers.
Biologic medicines naturally have a higher price than traditional medicines due to the more complicated and expensive production process of organic molecules compared to small-molecule drugs. Aspirin requires arranging only 21 atoms into the proper chemical structure; biologics may require 20,000.
However, even with these complex molecules, often part of the price comes from blocking competition. Only 2 percent of prescriptions in the United States are biologics, yet that accounts for 37 percent of drug spending.
Unlike generic versions of small-molecule drugs, biosimilars are not automatically considered interchangeable with the original version. The FDA’s dual-track system for approving biosimilars — one pathway for basic biosimilars and another pathway for “interchangeable” biosimilars — is an outdated and costly way to regulate biosimilars.
Many states do not allow drug substitution unless the FDA has approved the medicine as interchangeable. So, until interchangeability standards are met, pharmacists may not substitute the less expensive biosimilar as they can for generic drugs.
The basic biosimilar approval requires manufacturers to prove the drug is as safe and clinically effective as the original product. To qualify for interchangeable status, they must also conduct expensive and time-consuming switching studies — despite already having demonstrated no clinically significant difference.
Such red tape doesn’t enhance safety; it increases the costs and delays the availability of less expensive, but equally effective, medicine. Lacking competitive pressure, it’s no coincidence that brand-name biologics like Humira still dominate the market. Humira retains 80 percent of the arthritis treatment market, even though there are at least nine biosimilar versions available. Patients and insurers end up footing the bill.
Humira typically costs insurers $2,129 monthly, compared to the “high-cost” biosimilar versions ($1,356 monthly) and low-cost versions ($775 monthly).
Other examples include Herceptin, which is used to treat certain breast and stomach cancers at $4,500 monthly. Six biosimilars have been approved for it, with none approved as interchangeable. The price for this treatment would not remain so expensive with six competitors driving the price down.
As of May 2025, of the 75 approved biosimilars only 21 are considered interchangeable, and those are for eight brand-name products. Eleven products have no interchangeable biosimilars, and only three products have all biosimilars designated interchangeable.
In contrast, European countries don’t impose these extra hurdles; as a result, they’ve seen broader adoption of biosimilars without compromising patient safety. In 2022, the European Medicines Agency officially supported automatic interchangeability for biosimilars. This has resulted in biosimilars reaching 50 percent market penetration within the first year.
The Senate’s Biosimilar Red Tape Elimination Act takes the right approach by treating biosimilars more like generics. Defaulting biosimilars to interchangeable status would empower pharmacists to substitute more affordable versions, driving down prices. In 2023, biosimilars saved American patients $12.4 billion. Removing the regulatory roadblocks could drastically increase those savings.
The solution is simple: let biosimilars compete and give patients effective, low-cost treatments. The Senate bill offers a straightforward fix to align pharmaceutical policy with science and patients’ needs. Giving patients access to affordable biosimilars would mean access to affordable medicine, lower costs across the board, and a healthcare system that actually works for the people it is intended to serve. It’s time to cut the red tape and give biosimilars the competitive footing they — and patients — deserve.
