Key takeaways:
Ozempic (semaglutide) is an injectable medication for Type 2 diabetes. It’s not considered a biologic, even though it’s made using living cells.
Ozempic is categorized as a peptide because it has a chain of 40 or fewer amino acids (protein building blocks). That means it’s approved and regulated through the same pathway as most other medications, such as blood pressure pills.
Most other medications in Ozempic’s class are also considered peptides. But there are a few exceptions being studied in clinical trials, including oral pills, such as danuglipron and orforglipron.
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Whether you or someone you know has been prescribed Ozempic (semaglutide), or you’ve read about it online, Ozempic has become a household name for many. And because of this, you may have heard all about Ozempic’s side effects, how it works, and more.
But what exactly is Ozempic? Does it belong to a special category of medications, like biologics, or is it considered just a regular drug? The short answer: Ozempic falls somewhere in between. It’s not exactly a biologic. And it’s different from many other medications found at the pharmacy, too. We explain why below.
Is Ozempic a biologic?
No. Ozempic isn’t considered a biologic.
Biologics are large, complex molecules that come from living sources. They’re usually given as injections or infusions. They also go through a special approval process with the FDA before hitting the market. And instead of generics, biologics have biosimilars. Common biologic examples include insulins, vaccines, and certain injections for cancer and autoimmune disorders.
Even though it’s not a biologic, Ozempic has a few similarities with biologics, including:
How it’s made: Biologics are often made using recombinant DNA technology. This is when DNA molecules are engineered to have desired features, copied by living cells, then modified and purified. Ozempic is made using a similar process.
How it’s absorbed: Similar to biologics, medications like Ozempic usually aren’t absorbed very well if you take them by mouth. This is due to their size and how they’re broken down in the stomach, which is why they usually come as injectables. However, researchers have found a way around this with Rybelsus, an oral version of Ozempic. Oral biologics, on the other hand, are still a work in progress.
Due to its chemical structure, Ozempic is actually considered a peptide. But what exactly is a peptide?
What are peptides?
When it comes to medications, the FDA defines peptides as compounds that have a chain of 40 or fewer amino acids (protein building blocks). Longer amino acid chains are considered proteins. And proteins fall under the category of biologics. One exception are peptide vaccines, which meet the definition of a biologic.
Ozempic has a chain of 31 amino acids, which is why it’s considered a peptide and not a biologic. Because of this, Ozempic was approved and is regulated through the same pathway as most other medications, such as blood pressure pills. This also means that in the future, generic versions of Ozempic — instead of biosimilars — can be made available.
Ozempic belongs to a class of medications called glucagon-like peptide-1 (GLP-1) agonists. These medications work by acting like a gut hormone called GLP-1. Most other medications in this class are also considered peptides.
Are all GLP-1 agonists considered peptides?
Not necessarily. Most of the FDA-approved GLP-1 agonists on the market are peptides. But there are several non-peptide GLP-1 agonists in clinical trials that may be approved in coming years. Examples include danuglipron and orforglipron.
Danuglipron and orforglipron aren’t peptides. And they aren’t made the same way as medications like Ozempic, either. Instead, they’re made by combining different chemicals together. This is similar to how most other medications are made.
Peptides such as Ozempic are made to look very similar to the GLP-1 found in the human body, but with a few tweaks to make it last longer. Danuglipron and orforglipron don’t mimic human GLP-1 in the same way, but they activate similar targets in the body.
What are some examples of peptides?
There are several peptides available on the market. Some of them are FDA-approved medications used to treat conditions such as Type 2 diabetes, chronic weight management, constipation, and more. Examples of FDA-approved peptides include:
Liraglutide (Victoza, Saxenda)
Tirzepatide (Mounjaro)
Setmelanotide (Imcivree)
Plecanatide (Trulance)
Bremelanotide (Vyleesi)
Good to know: Unapproved, experimental peptide injections are also sold online. They’re often advertised for performance enhancement, weight loss, or other uses. We don’t have research on their safety and effectiveness, and they may not be intended for human use. Examples of these experimental peptides include BPC-157, ipamorelin, and research-grade versions of semaglutide (Ozempic’s active ingredient).
The bottom line
Ozempic (semaglutide) is an injectable peptide medication for Type 2 diabetes. It’s not considered a biologic because it has a chain of 40 or fewer amino acids. This means it’s approved and regulated through the same pathway as most other medications.
There are many FDA-approved peptides available, including other GLP-1 agonists besides Ozempic. But there are also unapproved and experimental peptides that are sold online. The safety and effectiveness of these peptides haven’t been confirmed.
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References
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Buckley, S. T., et al. (2018). Transcellular stomach absorption of a derivatized glucagon-like peptide-1 receptor agonist. Science Translational Medicine.
Eli Lilly and Company. (2023). Lilly's phase 2 results published in the New England Journal of Medicine show orforglipron, a once-daily oral nonpeptide GLP-1 receptor agonist, achieved up to 14.7% mean weight reduction at 36 weeks in adults with obesity or overweight. PRNewswire.
European Medicines Agency. (2017). Assessment report: Ozempic.
Griffith, D. A., et al. (2022). A small-molecule oral agonist of the human glucagon-like peptide-1 receptor. Journal of Medicinal Chemistry.
Khan, S., et al. (2016). Role of recombinant DNA technology to improve life. International Journal of Genomics.
Kim, H. S., et al. (2021). Oral semaglutide, the first ingestible glucagon-like peptide-1 receptor agonist: Could it be a magic bullet for type 2 diabetes? International Journal of Molecular Sciences.
Mahapatra, M. K., et al. (2022). Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes. Reviews in Endocrine & Metabolic Disorders.
National Archives Federal Register. (2020). Definition of the term “biological product”.
New, R. (2020). Oral delivery of biologics via the intestine. Pharmaceutics.
Pfizer, Inc. (2023). Pfizer provides update on GLP-1-RA clinical development program for adults with obesity and type 2 diabetes mellitus. Business Wire.
U.S. Department of Health and Human Services. (2021). ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin.
U.S. Food and Drug Administration. (2015). Frequently asked questions about therapeutic biological products.
U.S. Food and Drug Administration. (2020). Vaccine development – 101.
United States Anti-Doping Agency. (2020). BPC-157: Experimental peptide prohibited under 2022 rules.
United States Attorney’s Office, District of Maryland. (2015). Owner of bodybuilding drug companies admits to selling misbranded drugs.
