What Are Biologics and Biosimilars? Definitions and Examples

Humira. Enbrel. Remicade. If you’re living with an autoimmune disorder, these medications may sound familiar. They’re part of a broader group of drugs known as “biologics” that come from natural or living sources. And if you’ve been prescribed a biologic, you may be wondering if a generic option is available.

But biologics don’t have generics. They’re more complex than medications made from chemicals, which makes them more difficult to copy. Instead, biologics have biosimilars. But what exactly are biosimilars? Let’s discuss.

What are biologics?

Simply put, biologics are medications that come from living organisms or other natural resources. But the process to make a biologic isn’t so simple. In this case, modern biotechnology allows scientists to take components from humans, animals, or other microorganisms and use them to make biologics.

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A variety of medications and vaccines are considered biologics. And for now, they’re mostly available as injections. Some biologics, like vaccines and insulins, are readily available at your local pharmacy. Others you can only get from a specific type of pharmacy (called a specialty pharmacy) or through your healthcare provider.

Since they’re more complex, biologics may cost more than other medications (like oral pills). So, they’re sometimes subject to step therapy. This means your insurance plan will only cover them after you’ve tried another medication first. Other insurance requirements or exceptions may also apply.

Biologics are commonly used to treat health conditions like autoimmune disorders, cancer, and diabetes. Some examples of biologics include:

• Humira (adalimumab)

• Enbrel (etanercept)

• Remicade (infliximab)

• Neupogen (filgrastim)

• Orencia (abatacept)

• Shingles vaccine

• Flu vaccines

What are biosimilars?

Brand-name medications will sometimes have lower-cost generic versions. But do biologics also have generic versions? Sort of, but not exactly. Instead, they have biosimilars.

Because of the complex nature of biologics, they’re difficult to copy. In other words, it’s almost impossible to make a medication that’s exactly the same, especially in bulk. Biosimilars are products with highly similar structure and function as their original (reference) biologic. They should also provide a similar benefit. Examples of common biosimilars include:

• Semglee (insulin glargine-yfgn), a biosimilar to Lantus

• Amjevita (adalimumab-atto), a biosimilar to Humira

• Inflectra (infliximab-dyyb), a biosimilar to Remicade

• Byooviz (ranibizumab-nuna), a biosimilar to Lucentis

Even though they’re highly similar, there can be some notable differences between a biosimilar and reference biologic. For example, the biosimilar may not be approved to treat all the same conditions or demographics. And you may have fewer formulation options, too.

How are biologics and biosimilars different from regular drugs?

Conventional medications, like blood pressure pills, are small molecule drugs. They’re made from chemicals, and they can easily enter your cells where they have an effect. Since they have defined structures, manufacturers can copy them more easily.

Biologics (and biosimilars) are large, highly complex molecule drugs. They’re developed using genetically engineered cells, and there can be slight differences each time they’re made. Because of this, the FDA regulates them differently than other medications.

What do biologics and biosimilars treat?

Biologics and biosimilars are made to treat complex medical conditions. Examples include the following:

• Cancer

• Diabetes

• Rheumatoid arthritis

• Macular degeneration

• Crohn’s disease or ulcerative colitis

You may be prescribed a biologic or biosimilar on its own, or in combination with a small molecule drug.

Why would you use a biosimilar over a biologic?

Similar to generics, biosimilars can help you save money on your prescription — with savings up to 30%. But this can depend on your specific insurance plan, which may prefer a biosimilar over an original biologic, or vice versa.

In some cases, a biosimilar may be considered interchangeable with its reference biologic. This is similar to how your pharmacist might automatically dispense a generic product instead of a brand-name product. This can make switching over to a biosimilar easier.

It’s important to note that not all biologics have a biosimilar. And if they do, the biosimilars may not be on the market yet. For example, Humira’s first biosimilar, Amjevita, was approved in 2016. But it wasn’t officially launched in the U.S. until January 31, 2023.

If you’re interested in switching from your current biologic to a biosimilar, talk to your healthcare provider. As mentioned above, the main reason for using a biosimilar over a biologic is affordability. So, it’s a good idea to check with your insurance plan, too. 

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Written by:

Lauren Chase

Lauren Chase manages the GoodRx drug database, ensuring that all data is accurate and up to date. During her time at GoodRx, she's improved the processes and quality of drug database management.

Edited by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

Reviewed by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

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