Biologics (Biologic Medicine)

What are biologics (biologic medication and drugs)?

Biologics are medications that come from organic life. Scientists produce biologic medications by removing organic proteins or genetic materials from cellular lifeforms and, when possible, reproducing them. This means scientists might have to clone genes that reproduce the proteins they need. Or they might implant altered DNA into a living cell and then reproduce it through the cell on a large scale.

Biologic medications are an example of biotechnology. That’s when scientists use biology (the study of living things) to develop new products and technology to address human problems. Biologic drugs (biopharmaceuticals) often treat difficult diseases that traditional human-made drugs can’t successfully treat. But biologics are also much more complicated and expensive to make than synthetic drugs are.

What are some examples of biologics?

Biologic medications and drugs include:

• Blood and blood products (like plasma) for transfusion.
• Tissues for transplantation, like a skin graft or bone graft.
• Vaccines that prevent infectious diseases.
• Insulin therapy for diabetes.
• Immunotherapy treatments for cancer.
• Stem cell therapy for blood disorders and blood cancer.
• Gene therapy to treat genetic diseases.
• Monoclonal antibody therapy (cloned antibodies).
• Biologic immunosuppressants for autoimmune diseases and asthma.
• Biologic DMARDs (disease-modifying antirheumatic drugs) for arthritis.

What are the advantages of biologics in preventing and treating disease?

Some of the advantages of biologic medications are:

• Vaccines prevent the spread of infectious diseases. Routine vaccinations save an estimated 3 million lives each year. Global vaccine efforts have even eliminated some diseases. And when a global pandemic like COVID-19 occurs, they’re essential to controlling the rapid spread. Vaccines are among the oldest biologics in medicine, and they’ve had a huge global impact.
• Blood and plasma transfusions save lives. Blood transfusions don’t only replace critical blood loss due to hemorrhage. They can also replace diseased blood with healthier blood or plasma (plasma exchange). Healthcare providers are using blood and blood products to treat blood disorders, blood cancers and neurological disorders by removing harmful antibodies in blood.
• Biologics are helping people with cancer live longer. Biologics are at the forefront of cancer treatment innovations, including stem cell therapy, gene therapy and immunotherapy. These treatments can complement other cancer treatments to help fight the disease from multiple angles. Biologics like G-CSF can also help you recover from radiation and chemotherapy.
• Biologics can treat chronic inflammatory and autoimmune diseases. Biologics can effectively control chronic inflammation and pain, preventing the need for corticosteroids. Corticosteroids can become less effective over time, and their risk of negative side effects increases the more you use them. Biologics are also more selective than non-biologic immunosuppressants. They can block specific inflammatory pathways in your immune system without blocking them all.

What are the disadvantages of biologics?

Some of the disadvantages of biologic medications are:

• Production and regulation are difficult. Biologics are large, complex molecules that scientists can only produce within living cells. Scientists can’t simply manufacture them like normal drugs. Production processes for biologics are much more complicated and sensitive to small changes. Scientists must thoroughly control each step to ensure the product is consistent. This means biologics take longer to bring to the market than other drugs, and they’re much more expensive.
• Biologics can trigger an immune response. Biologics are more likely to raise a red flag in your immune system than normal drugs. Since biologics resemble living organisms, your immune system might mistake the medicine for an infection. It might activate to remove the medicine or build antibodies against it, making it ineffective. In some cases, biologics might trigger an allergic reaction. Allergies usually target proteins, and many biologics are proteins.
• Most biologics are injections. For the most part, biologics don’t come in pill form. Some are available as self-injections, and some are IV infusions that you get at your provider’s office. Most people don’t have reactions, but injections can cause reactions like pain, swelling or a rash. Some people get a fever or feel nauseous afterward. Most reactions are mild, and you may not have any. But if you do, or if you don’t like needles, you may be less likely to take the medicine.
• Immunosuppressants can make it easier for you to get infections. Biologic immunosuppressants, like TNF inhibitors, now treat a wide range of chronic inflammatory diseases, from rheumatoid arthritis to inflammatory bowel disease (IBD). But immunosuppressants (whether biologic or not) have the side effect of making you more vulnerable to infections. They can also slightly raise your risk of getting certain cancers. You and your healthcare provider will weigh these and other risk factors against the potential benefits of the medicine.

Should I ask my doctor about biologics?

Depending on your condition, your healthcare provider might suggest biologic medications right away. Or they might suggest other treatments first. Other treatments might be easier to get and treat your condition successfully. But biologics have been life-changing for people with certain severe chronic conditions that haven’t responded to other treatments. They could be the next step for you.

A note from Cleveland Clinic

While ordinary drugs will always have a place in healthcare, biologics are, in many ways, the future of medicine. Scientists are using biotechnology to target diseases more precisely and effectively, and often with fewer side effects. Research continues to refine this technology and develop new treatments for new conditions. There’s hope that gene therapy might one day target currently uncurable diseases.