California Is One Vote Away from Affordable Medicine
These are not patents of innovation – they are instruments of delay, designed to financially exhaust biosimilar developers in litigation
By Jim Relles, August 26, 2026 2:56 pm
A single injection of a biologic drug prescribed for rheumatoid arthritis can cost more than $5,000. The FDA-approved biosimilar equivalent — proven in rigorous clinical testing to deliver the same therapeutic outcome with the same safety profile — can cost a fraction of that. Both drugs treat the same disease. Both meet the same federal safety standards. For a patient with multiple sclerosis, Crohn’s disease, psoriasis, or cancer, that price difference is real. It can be the difference between staying on treatment and rationing doses, between managing a disease and surrendering to it.
Biosimilars exist to close that gap. They are not experimental alternatives — they are proven medicines, developed through some of the most sophisticated bioengineering science practiced anywhere in the world. The FDA reviews and approves biosimilars through a rigorous pathway that demands demonstrated equivalence in structure, safety, and clinical effect. More than 60 biosimilars have been approved in the United States. The science is not in question.
What is in question is whether the benefits will make it to Californians struggling to manage healthcare costs. Brand-name biologic drugs represent just 5 percent of all prescriptions written in the United States, yet they account for 51 percent of total drug spending. Biosimilar market share, despite years of FDA approvals, remains below 20 percent — not because physicians doubt them, not because patients reject them, but because brand-name biologic manufacturers have spent years constructing legal obstacles and barriers to keep competitors out. A 2026 study published in The Journal of the American Medical Association (JAMA) Health Forum found that among 331 analyzed drugs, manufacturers had filed 3,242 patents with the FDA — 54 percent covering devices or packaging features, with only 4.2 percent protecting the actual active medicine.
These are not patents of innovation. They are instruments of delay, designed to financially exhaust biosimilar developers in litigation and preserve monopoly pricing on the drugs patients need most. The Federal Trade Commission has now called this out directly, putting the pharmaceutical industry on notice for anti-competitive conduct. When biosimilars are introduced in the market, competition is increased and as a result, prices fall, and more of these life-savings medications reach patients. The industry knows it; that’s the point.
The cost of this obstruction lands hardest on the Californians who can least afford it. Since 2017, health plan spending on prescription drugs in this state has risen by $6.2 billion. These higher costs are felt every month by the person with rheumatoid arthritis rationing their injections because the refill cost more than their car payment, by the multiple sclerosis patient watching their insurer cover less each year, by the parent of a child with Crohn’s disease who has quietly learned to cut doses in half.
Biosimilars have already generated more than $36 billion in savings nationally since 2015, and $12.4 billion in 2023 alone — savings that materialize only when biosimilars can actually reach patients. The question before California’s legislature is whether this state will dismantle the barriers Big Pharma has created.
Senate Bill 1094 is the answer. The legislation would allow a pharmacist to substitute an FDA-approved biosimilar for a brand-name biologic when the prescribing physician has not identified any clinical reason not to do so. This is the same framework California has used for small-molecule generic drugs for decades, now applied to a newer class of medicines that have earned the same evidentiary foundation. The physician’s clinical authority is not overridden. What changes is that a patient standing at the pharmacy counter with a prescription for an $8,000-a-month biologic would now be offered a lower-cost option.
Opposition to SB 1094 has been framed around patient safety, a concern the clinical evidence has already addressed. Interchangeable biosimilars have been shown in clinical studies to produce the same outcomes as brand-name products. The European Union has operated a biosimilar substitution framework for nearly two decades without the safety crises opponents here predict. The argument against SB 1094 is not a scientific argument. It is a revenue protection argument, made at the direct expense of the patients the pharmaceutical industry claims to serve.
The science of biosimilars is mature and settled; the FDA has done its job, and the savings are real and documented. SB 1094 asks only that California stop Big Pharma from manufacturing legal barriers at the patient’s expense.
Key data sources: FDA Biosimilar Development Program; Association for Accessible Medicines 2024 Savings Report (IQVIA Institute); JAMA Health Forum (2026); California Department of Managed Health Care (December 2025); HHS Office of the Secretary.
- California Is One Vote Away from Affordable Medicine - August 26, 2026




