By Dylan McWilliams, Student Pharmacist
With Karen L. Kier, Pharmacist on behalf of the ONU HealthWise team
The idiom known as “the same, but different” is a saying commonly used in Southeast Asian countries and especially in Thai culture. The meaning indicates there is a fundamental difference, but with the slightest similarity.
Generic drug medications are actually the opposite of this idiom, being fundamentally similar with some slight differences. These differences could be in the inactive ingredients or the color or shape of the pills, which do not alter the therapeutic effect of the drug. Generic drugs are considered small molecule entities, but new biosimilar drugs entering the market are very large molecules in comparison.
The United States is full of competition and this is something that does not stop with drug manufacturers. When the first large molecule drugs were approved by the Food & Drug Administration (FDA), drug companies wanted to duplicate this process similar to a generic drug.
The challenge is that these medications are not as easy to recreate, compared to their generic small molecule counterparts. The drug molecules that compose some of these injectable medications are considered to be “large molecules” consisting of hundreds of molecules making up complicated drug structures.
So, how would a drug manufacturer create a generic copy of these large molecule drugs? The FDA created a new category called biosimilars to allow manufacturers to compete in this market. A biosimilar is a biologic medication (large molecule) that is of similar composition with the same therapy benefit as the original product, but made by a different company.
Insulin is a good example of a large molecule drug with commercially available biosimilars on the market. The original insulin glargine product was manufactured by Lilly under the brand name of Lantus®. There are now multiple biosimilars on the market for Lantus®.
Aside from insulin, another large molecule drug waiting for market release of created biosimilars is adalimumab (Humira®) used for rheumatoid arthritis (RA). This medication works by targeting inflammatory cells in the body called cytokines. Cytokines can be compared to communicators within the body and play a vital role in cell growth, inflammation and immunity for anyone who does not have RA.
For those diagnosed with RA, two specific cytokines, tumor-necrosis factor alpha (TNF-a) and interleukin-1, are present in large numbers and cause damage instead of protection. Humira® acts by blocking these cytokines from doing their job within the body to ensure damage is not done.
Humira® was first approved by the FDA in late 2002 and since then it has been approved for other conditions like Crohn’s disease, ulcerative colitis and plaque psoriasis. Ever since it was approved, Humira’s manufacturer AbbVie has had market exclusivity with no biosimilar competition.
As research and development for pharmaceuticals has progressed, scientists have found ways to mimic Humira® by changing small parts of the molecule. These small changes to the molecule do not change the way the medication works within the body, but this allows manufacturers to compete with the original product to treat these disease states.
The FDA approves biosimilars because they behave within the body the same way and produce the same benefits for patients. This process is not new, as the first biosimilar medication was approved back in March 2015 for an anti-cancer agent called filgrastim.
These biosimilars undergo the same testing and approval as any other medication allowing patients to know they are receiving therapy approved by the FDA after providing evidence of benefit. The FDA actually has a whole database for these medications called the Purple Book, allowing patients and providers to research all of the biosimilars approved for a specific medication.
Using Humira® as an example, there have been eight biosimilar medications approved for use within the United States. Their brand names are AbriladaTM, AmjevitaTM, HadlimaTM, Hulio®, Hyrimoz®, Idacio®, Yuflyma®, and Yusimry®. In January 2023, Amjevita™ was available within the U.S. market as a biosimilar to Humira®. More biosimilars for Humira® are available as of July 1, 2023.
Each of these medications was approved by the FDA since the mid-2010s, but were not commercially available as AbbVie had a 12.5-year exclusivity for the molecule; this prohibited the marketing of any biosimilar medications before 2023.
These medications work the same way and have similar side effects; the difference is a lower cost option. For example, Amjevita™ has a price tag for pharmacies 55% cheaper than Humira®. The idea is to ensure patients have access and can afford their medications.
If you are interested in switching to a biosimilar, it is important to discuss this with your healthcare provider along with your pharmacist. It is important to check with your pharmacist about the availability of the biosimilars as they enter the market.
So, they are really the same, but slightly different!
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