3/29/2022
The subclass of medications called biosimilars has been getting increased attention lately. Some of you may already be familiar with biosimilars and their place on the spectrum of spondyloarthritis (SpA) treatment options, but others may be wondering: What are these drugs? Why are they important, and what do I need to know? Why all the talk of biosimilars now?
To understand the potential implications of biosimilars it may be helpful to understand the nature of biologic drugs, which are made from living organisms. The material these medications are made from can come from many sources, including humans, animals, and microorganisms such as bacteria or yeast. Biologics are different from, and much more complex than, conventional medications.
Biological products are manufactured through biotechnology, derived from natural sources, or, in some cases, produced synthetically. And, biosimilars are just what the word implies: similar. A biosimilar is a type of biologic that is highly similar to another branded product. It has also been called a copycat version.
The FDA has deemed these medications similar enough to the originator medication that they can be called biosimilars.1 In other words, the FDA approved them to be as safe and effective as the original, with no clinical differences.
One reason biosimilars are a hot topic right now is because in 2023, the TNF inhibitor Humira is set to lose patent protection in the U.S. This will open the door to a wave of biosimilars becoming available to those who live with SpA.
SAA sat down with our own Chief Mission Delivery Officer, Richard Howard, to discuss the benefits and drawbacks of biosimilars, availability and cost, and other issues that may affect patients as these new medications come to market. Read on below for our interview.
SAA: What are some of the new biosimilars that will become available next year? And how can you tell a biosimilar from its originator medication?
RH: There are six biosimilars already available on the U.S. market3 with at least five more coming out next year. The biosimilars that are approved by the FDA and currently available in the U.S. are for infliximab and etanercept (Remicade and Enbrel). The biosimilars for Humira will become available in the U.S. starting in 2023.
You can tell if a medication is a biosimilar by the name. If there are four letters added onto the end of its name, then it’s a biosimilar. For example, one of the first approved biosimilars for infliximab (Remicade) is called infliximab-dyyb. SAA advocated for this naming convention as a matter of public safety and transparency. The first of a new subclass of biosimilars was also recently approved: interchangeable biosimilars. An interchangeable biosimilar is a biosimilar that was determined by the FDA to be safe and effective for patients to switch back and forth between the original and the biosimilar.2
SAA: Can we talk about the benefits of having biosimilars available on the market? Do they lead to lower medication costs for patients?
RH: Great question. Our bottom line is the out-of-pocket cost for SpA medications. The retail prices of TNF inhibitors have already come down because of biosimilars in the marketplace. So if a person doesn’t have health insurance, they would pay less. As the price of medications comes down, there could be billions in savings for the overall healthcare system. However, I suspect there are too many other factors involved that we would actually see peoples’ insurance premiums come down because of this. The retail prices of biologics can be up to $84,000 per year. Biosimilars are less expensive, but for all biologics the co-pay and the deductible amount together could add up to a heavy burden, year after year.
Many people are eligible to have the out-of-pocket price of a biologic reduced by manufacturer’s co-pay assistance—some pay as little as $5 with co-pay assistance. However, insurance companies often add an insidious clause to their plans called a co-pay accumulator. With co-pay accumulator provisions, companies get to keep the co-pay assistance themselves and not count it toward a person’s deductible. We have fought to ban co-pay accumulators in some states (on our advocacy page, we have a list of states in which we have been successful in blocking that double dipping practice).4
SAA: What are the potential downsides of biosimilars? Might people on brand-name medications be forced to switch by their insurance companies?
RH: Yes, I would say that is a real possibility. At SAA, we advocate for the idea that treatment decisions are best made between the person living with SpA and their healthcare provider. But we all know that what your insurance company is willing to pay for is a major factor in that decision. It’s possible that a person could be switched multiple times to different biosimilars. All of this is happening with a population that on average had to endure seven to 10 years of symptoms and damage before receiving an accurate diagnosis, and then often had to try several treatments until they found the one that currently works. So I’m not surprised that in a poll we did last year, 47% of respondents were interested in meeting with their legislature if needed on this topic.
Most states don’t have strong step therapy laws. Step therapy is a practice in which a patient is required by insurance to fail medications before they are approved for the drug their doctor prescribes. Unless there are strong step therapy laws in place, doctors and patients are not likely to have a choice if the person is switched to a less expensive medication.
SAA: Are there any other advocacy issues at play that patients should be aware of?
RH: There is definitely overlap when it comes to advocacy issues. I already mentioned the co-pay accumulator provision that nullifies the benefit of co-pay assistance. Some states have passed step therapy laws that, among other things, prevent a person who is stable on a medication from being forced to switch to another medication. I frankly don’t know if that would apply to a biosimilar, since I haven’t heard that tested. After all, the FDA recognizes biosimilars as not clinically different from the original.
More generally, this is an access issue. Do people have access to the medications they need? Access includes advocating for affordability and innovation. Although we have many more treatment options than we had 20 years ago, there is still an unmet need because the current medications are not effective enough or tolerated well enough by everyone with SpA. So I think there is a strong case in favor of advocating for research to understand the disease, creating even more effective treatments, and developing precision medicine. Finally, I think advocacy is needed to raise awareness of our disease. Greater awareness could shorten the delay in accurate diagnosis and raise interest in research.
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