2/17/2023
By Andy Wheaton PharmD., director of pharmacy benefits at Network Health
Even if you’re used to regularly taking prescription medications, navigating medication options can be daunting. Pharmacy developments are happening all the time, and you’ve likely seen more than a few commercials for new drugs on TV.
Biosimilars are exactly such a development in recent years. You‘ll be hearing a lot more about them, especially as a recently released biosimilar is poised to offer an alternative to Humira, a medication used for inflammatory conditions such as rheumatoid arthritis. More of these biosimilar competitors are expected in the months and years to follow, not only for arthritis, but for a number of illnesses including kidney conditions, skin diseases and cancer.
To understand biosimilar medications, however, you will first need to understand biologics. Put simply, biologics are medications that usually come from living organisms, such as cells or microorganisms like bacteria.
Most conventional drugs are chemically synthesized and are therefore developed using a chemical formula. Because they use living organisms, biologics are more complex and cannot be made by following a similar chemical formula. Being alive means that biologics can also be susceptible to heat and contamination, making these drugs costly to produce, and in turn, costly for consumers to purchase.
Common biologic medications include the following.
With that information in mind, what is a biosimilar then? The differences between a biosimilar vs. a biologic medicine may seem to be only a matter of title.
In fact, a biosimilar is itself a biologic. It is also a highly similar “replica” of a biologic drug already approved by the Food and Drug Administration (FDA). For example, one such biosimilar for Humira is known as Amjevita. These biosimilars are administered in the same way as the original biologic, and they also have the same strength, recommended dosage and potential side effects.
Therefore, from a clinical standpoint, there are no meaningful differences between a biosimilar and its original biologic medication. Of course, the drugs are made by different companies and are technically different, but in practice, those who take a biosimilar instead of the original biologic should expect no differences whatsoever.
Like the original biologic, biosimilars also undergo an approval process by the FDA, which includes studies, tests and data analysis to ensure the drug is safe and effective. Even after approval, the FDA continues to monitor biosimilars, ensuring they meet standards and reviewing any patient safety reports.
So, what benefit is there to taking a biosimilar instead of the original biologic? A biosimilar is often superior to its original biologic counterpart in one significant way, and that is cost.
The original biologic has already undergone extensive scrutiny, time and testing required to receive initial FDA approval. As you might imagine, this can cost a lot of money. Therefore, a biosimilar does not require the same level of research and development funding as the original biologic. This means the biosimilar costs less to produce and bring to market, a cost savings that can benefit you when you purchase the drug.
[Read more: Medication Prices Dictate Quality of Care]
With biosimilars on the market, patients can have more drug options to choose from and may be able to pay lower costs for the drugs they need. In turn, this creates more competition instead of having one particular drug brand dominating a market.
Sometimes, these biosimilars will require a new prescription from your personal doctor or the health care provider who prescribed the original biologic medication. The exception is if the biosimilar is considered interchangeable.
If you switch to an interchangeable biosimilar, you do not need a new prescription. The pharmacy you pick up your prescriptions from can make the substitution for you without another prescription.
Keep in mind, though, that just because a drug is a biosimilar it doesn’t mean that it is interchangeable. Biosimilars are approved by the FDA, but interchangeable biosimilars must meet additional requirements in order for them to be swapped with the original biologic without a new prescription.
To be approved as an interchangeable biosimilar, the drug manufacturing company has to provide data that shows how it will be used by patients. They also conduct studies that must show no decreased effectiveness or increased risk when switching to the biosimilar versus the referenced biologic. Keep in mind that even though an interchangeable must undergo an additional approval process, this does not mean that non-interchangeable biosimilar drugs are any less effective or safe.
Though biosimilars have been around for several years, they are just now starting to increase in availability. The Humira biosimilar options we mentioned earlier aren’t the only ones currently on the market. There are FDA-approved biosimilars for original biologic medications like Lantus, Avastin, Lucentis, Neulasta, Herceptin and more.
If you would like to explore currently approved biosimilar options, you can see a full list on the FDA website. We have no doubt that more will be added in the coming months and years, so talk to your personal doctor or pharmacist about possible biosimilar substitutes for any biologic medications you might be taking.
If you have a Network Health plan can direct questions to our pharmacist line by calling 888-665-1246 (TTY 800-947-3529), Monday – Friday from 8 a.m. until 5 p.m. Questions can also be emailed to pharmacist@networkhealth.com. If you would like to know if a specific medication is a covered drug under your health plan, use our online medication lookup tool.