Biosimilars: What Are They and Why Should You Care?

pharmacists at the pharmacy giving information to patient

Biosimilars are biologic medications similar to a reference product (original FDA-approved medication). They must work the same in the body, have the same dosage form, strength, and route of administration (e.g., injection). They are a safe and effective lower-cost option used to treat many conditions. 

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Have you ever wondered why your injectable medications are not available as generics? Generic pills are less expensive – so why can’t other medications follow suit? Well, there is, and they are!… sort of… 

“Generic” is to “brand” as “biosimilar” is to “reference product.” Huh? Let me explain.  

Making Logic of Your Biologics 

Biological medications (also known as biological products or simply “biologics”) are large, complex molecules (e.g., proteins, cells, tissue) made from living organisms (e.g., mice, plants, bacteria). Because of this, they are much harder to produce than a typical pill you might take.

 Biologics are almost always injectable medications and are used to treat diseases like psoriasis, arthritis, Chron’s disease, irritable bowel syndrome, cancer, and others. Examples include names you may have heard of like Humira®, Enbrel®, and Neulasta®. Biologics are the fastest-growing class of therapeutic products in the United States!

You Say Reference Product I Say Biosimilar

A reference product is the original FDA-approved biologic. A biosimilar is very similar to the reference product. Biosimilars are made from the same type of living organism as the reference product and must have similar characteristics – they must work the same in the body and have the same dosage form, strength, and route of administration (e.g., injection). 

There are no clinically meaningful differences between the two, which means you can expect the same efficacy and safety. Both must also go through FDA approval before they are marketed and used in the United States. 

Ok, ok… If they are basically the same thing, why have a biosimilar in the first place, and why don’t we just call them generics?

Generic vs. Biosimilar

When explaining this potentially new concept of biosimilars, it is easy to relate it to the often-familiar concept of generic medications. They both offer FDA-approved, lower-cost alternatives to their original counterparts. However, there are important differences between “generics” and “biosimilars”:

  • Structures (size and complexity)
  • Manufacturing practices (made by machine vs. grown in a living organism)
  • Testing requirements to show similarities
  • FDA approval pathways
  • Regulatory requirements and patent laws
  • Interchangeability (biosimilars are not automatically interchangeable in all states)
  • Naming conventions
  • You may not know about or see these specifics as a patient, but if you’re curious, there is a lot more detailed information on the FDA website

Biosimilar Benefits 

Although biosimilars are pretty new to the United States (the first one was approved in 2015), Europe has been using them for much longer (their first biosimilar was approved in 2006). The United States has learned a lot from Europe’s experience with these products from a clinical and safety standpoint. With the way the American healthcare system works, there are several important benefits to having biosimilars on the market, including: More Options  More Market Competition  Lower Costs  Increased Access to Important Medications 

Nuts and Bolts – Talking with Your Healthcare Team

Reference List

1. Patient Materials. U.S. Food & Drug Administration. Updated March 23, 2020. Accessed July 2, 2020.

2. Understanding Biologic and Biosimilar Drugs. American Cancer Society Cancer Action Network. 27, 2018. Accessed July 2, 2020.

3. Biosimilar and Interchangeable Products. U.S. Food & Drug Administration. Updated October 23, 2017. Accessed July 2, 2020.

4. What Is A Biosimilar? U.S. Food & Drug Administration. Accessed July 2, 2020.

5. Biosimilar Basics For Patients. American Pharmacists Association. Accessed July 2, 2020. 

6. Biosimilar Basics. U.S. Food & Drug Administration. Accessed July 2, 2020.

7. Biosimilars. U.S. Food & Drug Administration. Updated February 3, 2020. Accessed July 2, 2020.

8. Biosimilar Product Information. U.S. Food & Drug Administration. Updated June 11, 2020. Accessed July 2, 2020.

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