For seniors who rely on certain treatments to manage a variety of diseases – including arthritis, diabetes, cancer and more – prescription medications are crucially important—but can also be extremely expensive. Many older adults and their caregivers are instead turning to another option to ease the financial burden: biosimilars.
Don’t be surprised if you haven’t heard of them before. The process for FDA approval wasn’t put into place by Congress until 2009, which was done in hopes of expanding access to medically necessary and life-saving treatments while also lowering costs by increasing competition.
If you’re looking for other options for your loved one’s necessary medications, take a closer look at biosimilars to see if they could be a viable alternative.
What is a biosimilar?
A biosimilar medication can be thought of in a similar vein as a generic. Both are similar versions of approved medications that may be more affordable, and both are rigorously reviewed by the FDA before they become available to the public. But while generic drugs are made from a chemical compound, biosimilars are made from naturally occurring and even living biological ingredients, such as proteins, blood and bacteria.
“In contrast to a chemical, which is synthesized and can be generally copied, a biologic medication is made from natural and living sources and cannot be exactly copied,” the FDA writes. “So, the information needed to demonstrate that a biologic is biosimilar to another biologic can be much more extensive than what is needed for a generic.”
Biosimilars are designed to be alternatives to common biological medications already approved by the FDA—known as the “original biologic” or the reference product. These new biosimilars have “no clinically meaningful differences” from the original biologic,” the FDA writes.
While biologics might also sound unfamiliar, many commonly used medications and treatments – including Botox, Embril and Humira – are well-known and widely used. And last July, the FDA approved Semglee, a crucial insulin drug for people with diabetes, as one of the latest biosimilars. An estimated 20% of biologics prescribed in the U.S. today have a biosimilar alternative.
Potential savings of biosimilars
Biosimilars can offer some pretty substantial savings—10 to 37% to be precise. In fact, the national savings from 2020 to 2024 is expected to add up to $100 billion, according to a report from The IQVIA Institute for Human Data Science. That’s a big chunk of change, but does it guarantee savings at the pharmacy for seniors?
“We have to make sure it’s on the formulary,” explained Amber Grant, RPh, a pharmacist based in Oregon. “It’s not black and white. The insurance has to approve. A lot of times there are contracts so they’ve got a financial incentive not to cover it. Sometimes insurance won’t cover it, so it will cost more in the end.”
Grant described how contracts with Lantus, for example – the reference biologic for Semglee (mentioned above) – mean that its biosimilar isn’t on many formularies, so switching away from the brand name would not help seniors who use insurance to purchase their insulin. Of course, for those without any form of insurance, the biosimilar treatment could make the difference in whether or not they are able to access their medication at all.
…for those without any form of insurance, the biosimilar treatment could make the difference in whether or not they are able to access their medication at all.
Regulated to be safe and effective
Of course, any potential savings would be meaningless if the cheaper version doesn’t work as well or isn’t as safe as the original. So, it’s encouraging to note that, like generics, biosimilars undergo in-depth FDA testing to ensure they’re safe, effective and of the same quality as the reference product. This process can actually be more intense for biosimilars, as it is much harder to replicate a reference product that has been produced with natural ingredients than it is to simply copy the molecular makeup of a chemically manufactured brand-name drug.
Biosimilars are required to be made from the same types of ingredients and delivered in the same manner as the brand-name biologic they’re referencing. The strength and dosage of the treatment are also required to be the same, and the same benefits and side effects must result from both. Some but not all biosimilars go through an additional evaluation to be labeled as interchangeable, which means pharmacies can switch out the prescribed biologics for biosimilars without involving the provider if the state they are licensed in allows it.
Most states allow biosimilars in one capacity or another, but regulations regarding their substitution vary. Your pharmacist is the best resource to help you navigate what’s available in your area, especially as laws change.
The FDA keeps a comprehensive list of biosimilars approved for use in the U.S., but prescribers and pharmacists alike are both great resources to discuss potential substitutions.
“Ask the pharmacy if there is a less expensive alternative. Is there anything similar? A different form or dose?” Grant encouraged, explaining that it doesn’t bother her if patients come to her with questions like this. “I don’t think there’s any problem with it. We’re happy to help. The majority of pharmacists will help with this.”
So, will you need a new prescription to make the switch? Not necessarily, Grant said. Interchangeables can be substituted by a pharmacist in most states, but if the two drugs aren’t “AB rated” – or bioequivalent – she said the change must be discussed with a doctor. There are other ways pharmacists can help seniors save money on their prescriptions, even if switching to a biosimilar is not feasible. Grant gave the example of switching between capsules and tablets as one may be drastically more expensive than the other, depending on the medication. She did this for someone recently, reducing the cost from from $200 to just $31.
The potential savings of biosimilars may also increase as more are approved and added to insurance formularies. Speaking with your prescriber or pharmacist is the best way to know if switching from a name-brand biologic to a biosimilar is the best choice for saving money.