FDA’s Biosimilar Product Approval Process: A Closer Look

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In March, the U.S. Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio) as a biosimilar to U.S.-licensed filgrastim (Neupogen). It is the first biosimilar product to be approved in the United States and will increase treatment options for people living with cancer.

The FDA considers a biosimilar to be a biologic product that is highly similar to a product that has already been approved and licensed for use in the United States. In 2010, a streamlined process for the approval of biosimilar products was created as part of the Patient Protection and Affordable Care Act. A biosimilar product is required to have the same active mechanisms, conditions of use, and administration method and dosage as the approved product. Only minor differences in clinically inactive components are allowable.

To submit a biosimilar product for FDA review, manufacturers must complete an application that includes the following data as evidence of a product’s biosimilarity:

  • analytical studies
  • animal studies (including a toxicity assessment)
  • clinical studies (or a single clinical study) demonstrating the product’s safety, purity, and potency in at least one of the conditions for which the already licensed product is approved for use (eg, an immunogenicity and pharmacokinetics or pharmacodynamics assessment)

For additional information on biosimilar products and the approval process, view the following FDA resources:

Biosimilar Biological Products Presentation:

FDA’s Biosimilars Webpage:

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