Learning About Biosimilars

A biosimilar is a medicine that works like another approved medicine called a biologic.

Biologics are made from living cells, not just chemicals. They can include proteins, antibodies, and other things that help fight disease.

Biosimilars are tested to make sure they work just as well as the original medicines. They are not exact copies, but the differences are very small.

Compared to the original medicine, a biosimilar:

• Is made using a similar process.
• Works the same way in the body.
• Has the same benefits.
• Has been shown to be as safe.
• Is given at the same strength and dose.
• Is given in the same way.

In the United States, the Food and Drug Administration (FDA) checks and approves these medicines to make sure they are safe.

Many medicines cost a lot, especially for people who need them for a long time. Biosimilars can help reduce treatment costs.

Other possible benefits include:

• Easier access to these medicines.
• More treatment choices.
• The same safety and effectiveness as the original medicine.

These medicines treat many serious health conditions. Some are long-term conditions. They are often used when the immune system, inflammation, or cancer is involved.

Conditions that may be treated include:

• Arthritis.
• Psoriasis and other skin problems.
• Crohn's disease and ulcerative colitis.
• Diabetes.
• Macular degeneration.
• Multiple sclerosis.
• Kidney disease.
• Certain cancers, including breast, lung, and colon cancer.
• Osteoporosis.

These medicines must work just as well as the original medicines. Before a biosimilar is approved, it is studied and compared to the original medicine.

It must also:

• Work the same way as the original medicine.
• Provide the same treatment benefits.
• Be just as safe and effective over time.

These medicines may have the same side effects as the original medicines. This is because they work the same way in the body.

Possible side effects may include:

• Reactions at the injection site.
• Tiredness.
• Headaches.
• A higher chance of infection.
• Allergic reactions.

Talk to your doctor about potential risks. You can let the doctor know about any concerns or side effects during your treatment.