Generics vs. biosimilars: What are they and how are they different?

A woman sits on the edge of her bed and checks a prescription label on her nightstand.

There may be more affordable options available for your prescription medications right now.

Prescription medications can be costly, especially if you have a chronic health condition. But as more medications lose their patent protection, new, less costly options become available in the form of generics and biosimilars.

What are generic medications?

Generics are FDA-approved medications that can be made once the patent of a brand-name medication expires. For example, atorvastatin is the generic version of the brand-name medication Lipitor®.

Generics are chemically identical to their brand-name medication counterparts. They have the same active ingredients, benefits, dosage form (e.g., pill, injectable), way of administering them, safety profile, and strength. But they cost up to as much as 85% less.

Because generic medications are chemically identical to the original brand-name medication, they go through a different FDA approval process. Generics don’t have to repeat the original clinical trials, which helps lead to cost savings. They only need to demonstrate their chemical equivalence to the original brand-name medication.

What are biosimilars?

While you’re probably familiar with generic medications, it’s less likely you’re familiar with biosimilars. That’s because they are relatively new in the marketplace. The FDA approved the first biosimilar in 2015.

Biosimilars are lower-cost versions of biologics, which are complex medications made from natural and living sources, such as sugars, proteins, animal or plant cells, tissues, yeast, or bacteria. Biologics often play a critical role in treating complicated illnesses like cancer, diabetes, and autoimmune disorders, and can be found in the form of therapeutic proteins, monoclonal antibodies, and vaccines.

Biosimilars are made with the same natural sources, are administered the same way, provide the same treatment and benefits, and have the same strength, safety, and purity as their original biologic counterparts, also known as the reference medication. They can only be manufactured once a reference medication is no longer patent protected.

One example of a biosimilar on the market is Semglee® (insulin glargine). It’s the first FDA-approved interchangeable biosimilar, meaning it can be potentially substituted for the brand-name biologic Lantus® (insulin glargine).

Biosimilars and generics aren’t the same

While both generics and biosimilars offer more affordable medication options, biosimilars may not be chemically identical to their reference medication. Natural and living ingredients can’t be copied exactly, resulting in minor variations between the biosimilar and its reference biologic. Biosimilars are also more complex than generics and require a more extensive FDA approval process.

Many more biosimilars are expected to launch in the market over the next decade, which could lead to significant savings for patients.

Talk to your pharmacist about your options

If you have questions about whether a generic or biosimilar medication is right for you, please reach out to your doctor or pharmacist. At Express Scripts® Pharmacy, our pharmacists are available 24/7 to go over your medication options, potential cost savings, and more.

Posted date: March 25, 2022


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