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What are biosimilars?

Biosimilars are FDA-approved drugs that are “highly similar” to an existing biologic drug. A common biologic used to treat HER2-positive breast cancer is trastuzumab (Herceptin®). There are several biosimilars to trastuzumab available to treat early and metastatic HER2-positive breast cancers.  

A few facts about biosimilars:

  • Biosimilars are used to treat breast cancer and also for supportive care to manage side effects of cancer treatment.
  • As the science behind breast cancer treatments advance, biosimilars are creating more treatment options.
  • The FDA requires manufacturers to prove there are no “clinically meaningful” differences in the safety, purity and potency (strength) between their biosimilar and the original biologic drug.

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