Biologics vs Biosimilar Drugs: How Do They Differ From Each Other?Specialty Infusion Blog
Biologics and biosimilar drugs might be two terms that you’re not familiar with regarding prescription medications. However, they are a lot more common than most people think.
Have you ever seen advertisements for Humira? Do you know about the flu and shingles vaccine? If you answered yes to either of those questions, you are well on your way to becoming familiar with biologics and biosimilar drugs.
We put together this guide to help you better understand what biologics and biosimilar drugs are and the differences between the two.
What are biologics?
Biologics are a class of prescription drugs that are made using living systems, such as microorganisms, plant cells, or animal cells. Since biologics come from diverse sources that can be hard to identify, they also tend to be more complex in their composition than conventional drugs. Even so, all biologics are regulated by the Food and Drug Administration (FDA).
What are biologics used for?
There are many complex conditions biologics have been approved to help treat. Some of these conditions include:
- Crohn’s disease
- Ulcerative colitis
- Rheumatoid arthritis
- Human immunodeficiency virus (HIV)
- Multiple sclerosis
- Growth deficiencies
How are biologics different from traditional drugs?
Traditional pharmaceutical drugs are made from chemicals, whereas biologics come from living organisms. Thus they have a more complex structure, larger molecules, and are not easily reproduced by following a “chemical recipe“.
Examples of biologics
Biologics are usually administered by injection or infusion. This is due to the fact that if they are taken orally, the process of digestion would break down the biologic, likely making it ineffective.
Examples of biologics currently available include:
What are biosimilar drugs?
Biosimilar drugs are a very similar copy of the original FDA-approved biologic drug, known as the reference product. The biosimilar presents no significant differences in its safety or efficacy from the biologic product.
The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 was created as an “abbreviated licensure pathway” for biological products to :
- provide more treatment options
- increase access to lifesaving medications
- possibly lower health care costs through competition
Are biosimilars the same as generic drugs?
Unlike generic drugs, biosimilars are not identical copies of their reference drugs. However, each biosimilar drug is manufactured in a complex process that includes the exact steps made to make the biologic medication. Still, small changes are common from batch to batch since biosimilars are made from living cells.
These variations are expected and acceptable because every lot is still required to meet the same high standards of purity, safety, and efficacy as per the guidelines of the FDA.
Examples of biosimilar drugs
Like biologic drugs, biosimilars are also FDA-approved and only available with a prescription from a healthcare professional. Some examples of biosimilars include:
Differences between biologic and biosimilar drugs
A biosimilar is extremely similar to the biologic and has no significant clinically differences from another biologic already FDA-approved.
This means that biosimilars:
- Are administered the same way as the original biologic
- Have the same strength and dosage form as compared to the original biologic
- Have the same possible side effects as the original biologic
- Provide the same potential treatment benefits as the original biologic
As stated earlier, because there is no “chemical recipe” to follow when making biologics, biosimilars are generally made with the same natural sources as the reference product, but could have slight variations.
Biologics and biosimilar are some of the fastest-growing segments of the prescription product market. As the FDA continues to approve additional biosimilar medications, patients will have more treatment options and potentially less expensive alternatives.
You can access the FDA’s purple Book database for more information about biologic and biosimilar drugs.
At Speciality Infusion Centers, we specialize in managing chronic conditions and work with you, your insurance carrier, and your healthcare doctor to provide a personalized treatment plan. Find the most convenient location for you to start on your biologic/biosimilar IV therapy today.