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Biosimilar Drug Safety

A biosimilar drug is a type of biologic drug — a medicine made from a biological or natural source. A biosimilar drug is a safe and effective, high-quality treatment that is “highly similar with no meaningful clinical differences” to a brand name biologic drug that’s used to treat a certain disease.

There are strict rules about how a biosimilar drug is tested for its safety, and what that testing needs to show. Just like any drug, a biosimilar drug is tested in clinical trials to make sure it is safe to use in people. The data from the clinical trials are carefully reviewed by the Food and Drug Administration (FDA) to be sure the biosimilar drug is just as safe and effective as its brand name biologic drug. If a biosimilar drug is approved by the FDA, this means it has met the strict standards for being safe. Learn more about how a biosimilar drug is tested inAfter a drug gets FDA approval to treat a certain type of cancer and is “on the market,” doctors can start using it. Doctors and other members of the cancer care team often give the FDA feedback about how they’re using drugs to treat people with cancer. This data is called post-marketing information. This information helps the drug companies and the FDA make sure drugs are still safe, meaning they are doing what they’re supposed to do and aren’t causing more side effects than what clinical trials showed. Just like for other drugs used to treat cancer, post-marketing information is collected for biosimilar drugs.

Are special precautions needed for biosimilar drugs?

Much is known about the need to protect others from exposure to chemotherapy (chemo) because it can be dangerous. This is why there are safety rules and recommendations for people who handle chemo drugs. However, because biologic (and biosimilar) drugs are newer, there is not as much information about long-term effects of exposure. To be safe, many experts recommend treating biologic drugs, including biosimilars, as hazardous and taking the same precautions as when handling chemotherapy. This is especially true because many biologic drugs are given along with other drugs that are known to be hazardous, so your cancer care team will take precautions to protect themselves and others from exposure to them.

A biosimilar drug is a safe and effective, high-quality treatment that is “highly similar with no meaningful clinical differences” to a brand name biologic drug that’s used to treat a certain disease.

How Do I Know Biosimilars Are Just as Safe as Reference Biologics?

Yes, biosimilars are absolutely safe. Every drug that’s been approved for your use by the FDA must meet very high standards of safety. This includes all biosimilars and biologics. They are prescription drugs, so in the U.S., the FDA regulates how they are manufactured and delivered to you.

While biosimilars follow a shorter track to FDA approval, their makers still must test them thoroughly to show that they’re highly similar in structure and function to their reference products, that they’re safe, and that they work to treat diseases as they should.

One note: Biosimilars are not required to be studied in all indications for which they will be approved for use. This is called extrapolation. If a biosimilar is approved for one indication of its brand name biologic — say rheumatoid arthritis — then all the indications of the brand name — psoriatic arthritis and ankylosing spondylitis, for example — are approved for the biosimilar.

In Europe, where biosimilars are more widely used, there are more than 700 million patient days of experience with biosimilars that illustrate their safety and efficacy in a real-world setting.

Expert Guidance from Cancer Coach

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