The Who, What, Where, When and Sometimes, Why.

Biosimilars

What is a biologic?

Some drugs are made from biological products (biologics) such as antibodies or proteins. Biologics come from all sorts of living things, such as animal cells, plant cells and bacteria.

Trastuzumab (Herceptin) and pertuzumab (Perjeta) are breast cancer treatment drugs made from biologics (they are antibodies). Other drugs, such as vaccines and insulin, are also biologics.

What is a biosimilar drug?

A biosimilar is a “generic-like” version of a drug that contains biologics.

A generic drug has the exact same active chemical ingredients as the original drug. It’s not possible to make an exact copy of a biologic because it’s a living thing. However, a biosimilar is highly similar to the original biologic drug and works the same way in the body. So, it’s a “generic” version of a biologic drug.

Biosimilar drug names

The name of a biosimilar includes the name of the original biologic drug. For example, trastuzumab-dkst is a biosimilar to the drug trastuzumab. Biosimilars also have brand names.

FDA approval of biosimilars

To be approved by the U.S. Food and Drug Administration (FDA), a biosimilar must work the same way as the original drug and it must [131]:

  • Be as safe when used alone or in combination with other treatments
  • Be as effective when used alone or in combination with other treatments
  • Have similar side effects (they can’t be different from those of the original drug)
  • Have the same form as the original drug (for example, if the original drug is given by vein (through an IV) the biosimilar must also be given by vein)

Once a biosimilar is approved by the FDA, health care providers can feel comfortable with their patients getting the biosimilar instead of the original drug.

Biosimilars for breast cancer treatment

The FDA-approved biosimilars for breast cancer treatment are all biosimilars to trastuzumab (Herceptin)

Other biosimilars are under study for the treatment of breast cancer.

Biosimilars to trastuzumab

Trastuzumab (Herceptin) is a HER2-targeted drug. It’s used to treat early and metastatic HER2-positive breast cancers.

Biosimilars to trastuzumab can also be used to treat early and metastatic HER2-positive breast cancers. They include (in alphabetical order):

  • Trastuzumab-anns (Kanjinti)
  • Trastuzumab-dkst (Ogivri)
  • Trastuzumab-dttb (Ontruzant)
  • Trastuzumab-pkrb (Herzuma)
  • Trastuzumab-qyyp (Trazimera)

Biosimilars used to treat side effects of breast cancer treatment

Some drugs used to treat side effects of chemotherapy and other breast cancer treatments are made from biologics. Some of these drugs have biosimilars.

For example, some people get filgrastim (Neupogen) or pegfilgrastim (Neulasta) to help maintain their blood counts during chemotherapy. Tbo-filgrastim (Granix) and pegfilgrastim-jmdb (Fulphila) are the biosimilars to these drugs.

Some insurance companies ask that these biosimilars be used instead of the original drugs, just as they ask for genetic drugs to be used instead of brand name drugs.

Biosimilar drug costs

Due to the complex manufacturing process, biosimilars are costly to produce. As more biosimilars become available, costs may go down over time.

It’s unknown how the cost of biosimilar will affect patients.

Talk with your health care provider

Your health care provider can tell you whether a biosimilar drug may be part of your breast cancer treatment plan. If you have questions about biosimilars, talk with your provider.