The National Foundation for Cancer Research (NFCR) answers some of the most frequently asked questions about biosimilar drugs for cancer treatment.

Biologic drugs (biologics) are a special class of medications that are made from living organisms, such as proteins. Vaccines, hormones, and anti-allergy medications are all examples of biologics. These medications treat some of the most deadly illnesses that affect people today, including certain cancers. However, because these drugs are more complex than other medicines and more difficult to manufacture and store, they are also much more expensive. As a result, some people who could benefit from the medications are unable to afford them.

That might soon be changing.

Biosimilar drugs (biosimilars) are medicines that closely mimic the structure and function of existing biologics. Because these medications are based on drugs that have already received approval from the U.S. Food and Drug Administration (FDA) following a rigorous research, development, and evaluation process, they can be developed more quickly and at a lower cost, potentially passing some cost savings along to the patients who need them. Below, we answer some of the most frequently asked questions about biosimilars and offer advice about steps that cancer patients can take if they believe they may benefit from switching to a biosimilar.

Are biosimilars the same as generic drugs?

Generic drugs are copies of brand name drugs; they work and are used in the same way as the brand name drug. While biosimilars are similar to generic versions of existing biologics, there are some key differences. Biosimilars are not exact copies of existing biologics, and the path to approval through the FDA for biosimilars is much different than the path used for generic drugs. The FDA also often requires much more information from studies that compare biosimilars to their original biologics than it requests from studies on generic drugs.

Are biosimilars safe to use?

Yes, biosimilars are very safe to use. Biosimilars are tested in clinical trials and must be approved by the FDA before health care providers can begin using them to treat patients. To be approved, a biosimilar must be “highly similar” to the original biologic and exhibit no “clinically meaningful differences” in safety, purity, and potency.

What successful biosimilars currently exist?

At this time, a number of biosimilars have been approved by the FDA to treat a variety of diseases, including cancers such as breast cancer, stomach cancer, and colorectal cancer. Some biosimilars treat the cancer itself, while others are used to help manage the side effects associated with other cancer treatments. Biosimilars currently approved for use in patients with cancer include:

• Filgrastim-sndz (Zarxio): A biosimilar for filgrastim (Neupogen), this medication helps the body fight infection.
• Bevacizumab-awwb (Mvasi): A biosimilar for bevacizumab (Avastin), this medication treats certain colorectal, lung, brain, kidney, and cervical cancers.
• Trastuzumab-dkst (Ogivri): A biosimilar for trastuzumab (Herceptin), this medication treats certain breast and stomach cancers.
• Pegfilgrastim-jmdb (Fulphila): A biosimilar for pegfilgrastim (Neulasta), this medication helps the body fight infection in people diagnosed with non-myeloid cancer.
• Rituximab-abbs (Truxima): A biosimilar for rituximab (Rituxan), this medication treats non-Hodgkin lymphoma.

For a complete list of approved biosimilars, please visit the FDA’s website.

How can biosimilars help lower the cost of cancer care?

Biosimilars can help lower the cost of cancer care because they provide additional treatment options for patients, which fosters market competition and can potentially help lower the cost of cancer treatment and facilitate greater access to biologics among cancer patients. However, it is important to understand that, because biosimilars are still an emerging treatment option, their impact on overall health care costs still remains unclear.

How can I determine if I am a good candidate for a biosimilar drug?

If you are a patient who has been diagnosed with cancer and have been prescribed a biologic by your health care provider, speak with your provider to determine if a biosimilar might exist for your therapy and if you would be a good candidate for it. Clinical trials for biosimilars are also ongoing. If you are interested in participating in a clinical trial, speak with your health care provider to see if you might be a good candidate.