What Are Biologics? 5 Examples of Biological Drugs You May Already Be Taking

Botox. Humira. Lantus. Enbrel. You may have heard of at least one of these medications before. But did you know that all of them are derived from living cells? These popular drugs are examples of biologics, or biological medications. Biologics are medications developed from blood, proteins, viruses, or living organisms. And they are used to prevent, treat, and cure many health conditions.

Biologics are different from most of the medications stocked on pharmacy shelves. In fact, they even go through a separate approval process with the FDA. And they don’t have generics. They have highly similar and less expensive versions called biosimilars. 

Chances are you or someone you know has taken a biologic. Here, we’ll cover what you should know about five popular biologic medications.

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What are biological drugs?

Biologics are powerful medications that can be made of tiny parts like sugars, proteins, or DNA. Or they can be whole cells or tissues. These medications also come from all sorts of living sources, such as humans, animals, and even bacteria.

Biological medications tend to be at the forefront of drug research today. Gene-based and cellular biologics, for example, are now making it possible to treat some illnesses where no other treatments used to be available.

Because they come from such diverse sources, biologics are usually much more complex than other medications. For example, they take a lot more work to purify, process, and produce. Once these medications are formulated, they also tend to be more unpredictable and are often more sensitive to light and temperature. These factors can make biologics more expensive.

Examples of common biologics

Biologics treat a broad range of common and rare diseases. They include vaccines, cell and gene therapies, tissues for transplants, and more. Here are some examples of biologics you may already be familiar with:

1. Lantus (insulin glargine)

Lantus (insulin glargine) is a long-acting insulin that people with diabetes sometimes use to control their blood sugar levels. It’s FDA-approved for adults with Type 2 diabetes, and for both adults and children (6 years and older) with Type 1 diabetes.

Insulin helps the body turn excess blood sugar into energy or store it in muscles, fat, and the liver for later use. People with diabetes have high blood sugar levels either because their bodies don’t make enough insulin, or their body doesn’t respond as well to insulin. Lantus raises insulin levels in the body to keep blood sugar levels under control.

Lantus has two FDA-approved biosimilars: Semglee (insulin glargine-yfgn) and Rezvoglar (insulin glargine-aglr). Semglee is currently available in pharmacies. And it’s interchangeable with Lantus. That means it’s easier to substitute Semglee for Lantus at the pharmacy. The launch date for Rezvoglar has yet to be announced.

2. Humira (adalimumab)

Humira (adalimumab) is a type of medication known as a monoclonal antibody. Monoclonal antibodies are artificial proteins used to target specific elements in your body. 

With rheumatoid arthritis, Humira prevents inflammatory processes that lead to joint inflammation, damage, and pain. It does this by blocking specific molecules in the body that would otherwise trigger inflammation. Humira works like other popular biologics, such as Remicade (infliximab) and Enbrel (etanercept) that also treat autoimmune diseases. 

The FDA has approved seven biosimilars for Humira. They are expected to be available in pharmacies in 2023. Cyltezo (adalimumab-adbm) became the first interchangeable Humira biosimilar in late 2021.

3. Herceptin (trastuzumab)

Approved in 1998, Herceptin (trastuzumab) was one of the first monoclonal antibodies for cancer. It’s used to treat HER2-positive breast cancer and HER2-positive metastatic stomach cancer. 

 Herceptin works by targeting HER2-positive cancer cells and limiting processes that cause cells to grow and multiply uncontrollably — hallmark features of cancer cells.

The FDA has approved five Herceptin biosimilars. Most recently, Kanjinti (trastuzumab-anns), Trazimera (trastuzumab-qyyp), and Ontruzant (trastuzumab-dttb) were approved in 2019.

4. Avastin (bevacizumab)

Avastin (bevacizumab) is a monoclonal antibody that’s FDA-approved to treat many different types of cancer, including colorectal cancer and brain cancer. It works by cutting off the blood supply to certain cancer cells that help them grow. 

Avastin is also used off-label to treat certain eye conditions, including age-related macular degeneration (AMD) and diabetic eye problems. New, leaky blood vessels grow in the retina that worsen these conditions. Avastin helps slow the growth of these blood vessels.

Avastin has three biosimilars: Mvasi (bevacizumab-awwb), Zirabev (bevacizumab-bvzr), and Alymsys (bevacizumab-maly). Alymsys was just approved in April 2022.

5. Botox (onabotulinumtoxinA)

Lastly, Botox (onabotulinumtoxinA) is a biologic produced by a bacteria called Clostridium botulinum. You may already know of Botox as a medication used in cosmetic procedures. But it’s actually helpful for many other conditions. 

Botox is a toxin that blocks nerves and muscles from activating. Aside from making wrinkles disappear, it is used to treat:

• Muscle spasms

• Neck spasms

• Underarm sweating

• Migraines

• Overactive bladder

• Loss of bladder control due to nerve damage

• Eyelid twitching

• Crossed eyes

Currently, there’s no Botox biosimilar available. It will likely be a few years before one is approved.

How are biologics different from other drugs?

Most medications in your medicine cabinet at home — from allergy pills to blood pressure medications — are called small molecule drugs. They’re made from chemicals. And you can find them in a variety of dosage forms, including capsules, liquids, and topical creams. 

In contrast, biologics are made from living sources. They’re mostly available as injections and infusions. But they can sometimes come as an inhaled medication. This is because oral biological drugs have been more challenging to make.

How are biologics approved by the FDA?

The process that the FDA uses to approve biologics is different, too. Small molecule drugs are submitted to the FDA for approval through a new drug application (NDA). This makes sure they’re safe and effective for their intended use. Their generic versions go through an abbreviated new drug application (ANDA) to show they’ll work just as well as the brand versions. 

Because of how they’re made, biologics go through a special FDA-approval pathway called a biologics license application (BLA). Since biologics are more complex, the BLA process focuses more on where and how the medication is made, compared to the NDA’s process. Biosimilar versions go through an abbreviated BLA process to show they’re highly similar to their FDA-approved biologic counterpart.

Are biologics more expensive than other drugs?

Another difference between biologic and small molecule drugs is cost. All but a handful of the most expensive medications in the U.S. are biologics. And the top three most expensive brand-name medications are biologics, too.

You can save up to 85% of the cost of a brand-name medication by opting for a generic. But the potential savings aren’t that large with biologics. Biosimilar versions are typically between 10% and 37% less expensive than their biologic counterparts. Plus, most biologics don’t have biosimilars yet.

If you’re having trouble paying for your biologic medication, manufacturer copay cards and patient assistance programs can help make them more affordable. But you may need to meet certain eligibility requirements first.

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Written by:

Benita Lee, MPH

Benita Lee, MPH, is director of content and operations at GoodRx and contributes to content strategy and process management across editorial and product initiatives. She is passionate about building collaborative teams and has a deep interest in using research to improve health outcomes in innovative and sustainable ways.

Reviewed by:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

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