The need for biosimilars

Dr. Knowles is a rheumatologist based in Carson City, Nevada. She is a native of Nevada who graduated from the University of Nevada School of Medicine.

Millions of Americans have autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and other debilitating conditions. Often, they suffer pain and damage to their joints, making the simplest of tasks a real challenge.

As a rheumatologist, I treat these patients with medications to help their symptoms and protect their joints from damage.

One class of medication called biologics has revolutionized the practice of rheumatology. They are very effective therapies that have enabled many people suffering with these conditions and others, such as cancer, psoriasis and Crohn’s disease, an opportunity to live a normal life.

Biologics are complex protein molecules, which inhibit specific components of the immune system, which subsequently decreases inflammation causing much of the damage in most rheumatic diseases.

However, biologics are very expensive. Some of them cost tens of thousands of dollars for a year of treatment. If state lawmakers are to expand access to care, they need to approve ways to make innovative treatments affordable. A bill being considered by the Nevada Legislature—Assembly Bill 245—addresses this need and more.

Generic drugs have helped bring down the cost of conventional, small-molecule drugs. Most patients and doctors have become comfortable substituting less expensive generics for the name-brand drugs.

The process is different for biologics. Because biologic medicines are manufactured using living organisms and natural processes, it’s impossible to create an exact copy.

There’s no such thing as a “generic biologic.” But scientists can create “biosimilars”—near-identical copies of biologics. These drugs have the potential to provide the same therapeutic effects as biologics at lower prices.

I believe passage of Assembly Bill 245, will help patients across the state gain access to cost-effective biosimilar medicines, which could provide much-needed relief to their health and their pocketbooks.

Additionally, this bill goes to great lengths to keep patient safety at the forefront. It ensures that pharmacists will not substitute a biologic medicine with a biosimilar, unless it has been deemed “interchangeable” by the Federal Drug Administration. This means the biosimilar is close enough to the original that it would be expected to have the same or very similar efficacy.

Still, because of a slight difference between the biologic and biosimilar, the bill requires patient notification and communication between the pharmacist and doctor in the event a biologic is substituted with an FDA-approved interchangeable biosimilar. This strengthens the team approach to patient care, ensuring a complete patient record.

Assembly Bill 245 gives physicians like myself an opportunity to provide life-changing medicines at a more affordable cost. So, I urge Nevada legislators to pass the bill and Gov. Brian Sandoval to sign it into law. Let’s not wait any longer to make sure Nevada patients get the best available and most affordable care.