Customize your JAMA Network experience by selecting one or more topics from the list below.
Biosimilars are medicines that are similar to other cancer medicines called biologics.
How Are Biosimilars Different From Generics?
Generic medicines are an exact copy of a brand-name medication. Manufacturers are able to make identical versions of a medication when the ingredients are simple chemicals. However, the ingredients in some medicines, such as vaccines, growth factors, or monoclonal antibodies used in cancer, are made from living cells and are too complicated to make into a generic version. These complex medications are referred to as biologics. Biosimilars are medicines that are very similar to these biologics but are not exact copies. The biologic medication that the biosimilar is based on is called the reference product.
How Are Biosimilars Approved?
To be approved by the US Food and Drug Administration (FDA), biosimilars must prove they are as safe and effective as their reference product. Manufacturers who make biosimilars must show that there are no clinical differences between the reference medication and the biosimilar. All biosimilars approved in the United States are highly similar to their reference product. The FDA does not require different studies to be conducted for every biosimilar indication.
What Are the Benefits to the Patient?
Similar to generic medication, biosimilars may provide cost savings to the health care system and potentially cost less for the patient than the reference biologic medication.
How Are Biosimilars Named?
Unlike generic medication, which can have the same chemical name as the brand name, biosimilars must include 4 lowercase letters after the name of the medication. For example, the biosimilar for the reference product filgrastim is called filgrastim-sndz. The biosimilar and the reference medication always have the same active ingredient. The addition of the 4 lowercase letters lets you know that the medication is a biosimilar.
Are Biosimilars Interchangeable With Biologics?
No biosimilar approved by the FDA is interchangeable with its reference product. Since the biosimilar is considered similar to the reference product, but may be cheaper, some insurance companies may only allow use of the biosimilar. Some state laws may permit your pharmacy to substitute a biologic for a biosimilar.
Should I Be Concerned if My Doctor Recommends a Biosimilar?
No. The FDA requires biosimilars to meet strict safety and efficacy requirements. Biosimilars must prove that they are similar to the reference product. Although the first biosimilar was approved in the United States in 2015, biosimilars have been used safely and successfully in Europe since 2007.
Biosimilars available in the United States today include filgrastim-sndz (reference product filgrastim), bevacizumab-awwb (reference product bevacizumab), and trastuzumab-dkst (reference product trastuzumab). The approval of additional oncology biosimilars is expected.
Biosimilars are safe, effective treatment optionshttps://www.fda.gov/biosimilars
Published Online: June 7, 2018. doi:10.1001/jamaoncol.2018.0999
Conflict of Interest Disclosures: None reported.
Parsad S, Nabhan C. Biosimilars. JAMA Oncol. 2018;4(7):1023. doi:10.1001/jamaoncol.2018.0999
Coronavirus Resource Center
Create a personal account or sign in to: