Biosimilars: What Are They and Why Should You Care?
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
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
- How do I know if my medication has a biosimilar? Check the FDA website or talk to your pharmacist or primary care provider. More biosimilars come out every year, so keep your eyes and ears open!
- Your insurance may not cover all related biologics (reference product and all its biosimilars). Check with your insurance company to see if they have a preferred product.
- Biosimilars are not automatically interchangeable in all states. So, for example, if your doctor prescribes a branded insulin product like Lantus®, but your insurance pays for the biosimilar Basaglar®, your pharmacist must call the prescribing provider for approval to make the change. This requirement may vary depending on state law – ask you pharmacist or primary care provider for more information about what is required in your state.
- For much more information and some frequently asked questions (FAQs) for patients, here are a few useful resources:
1. Patient Materials. U.S. Food & Drug Administration. https://www.fda.gov/drugs/biosimilars/patient-materials. Updated March 23, 2020. Accessed July 2, 2020.
2. Understanding Biologic and Biosimilar Drugs. American Cancer Society Cancer Action Network. https://www.fightcancer.org/policy-resources/understanding-biologic-and-biosimilar-drugs.Published 27, 2018. Accessed July 2, 2020.
3. Biosimilar and Interchangeable Products. U.S. Food & Drug Administration. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products#reference. Updated October 23, 2017. Accessed July 2, 2020.
4. What Is A Biosimilar? U.S. Food & Drug Administration. https://www.fda.gov/media/108905/download. Accessed July 2, 2020.
5. Biosimilar Basics For Patients. American Pharmacists Association. https://www.pharmacist.com/biosimilar-basics-patients?is_sso_called=1. Accessed July 2, 2020.
6. Biosimilar Basics. U.S. Food & Drug Administration. https://www.fda.gov/media/130918/download. Accessed July 2, 2020.
7. Biosimilars. U.S. Food & Drug Administration. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars. Updated February 3, 2020. Accessed July 2, 2020.
8. Biosimilar Product Information. U.S. Food & Drug Administration. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Updated June 11, 2020. Accessed July 2, 2020.