Biosimilars

Biosimilars are products that are extremely similar to an existing manufactured product. Biosimilars are a type of biologic product, which can include a variety of products such as vaccines, blood elements, gene therapy, tissues, or proteins. Biologics typically come from living organisms (ie, humans, animals, microorganisms, yeast). They are used in patient treatments such as:

  • Cancer
  • Kidney disease
  • Autoimmune disease (ie, rheumatoid arthritis and Crohn disease)

A biologic is considered a biosimilar if the product shows it is “highly similar” to biologic product that has already received approval from the US Food and Drug Administration (FDA). To prove that a biosimilar is “highly similar” to the original manufactured product, the biosimilar manufacturer must take a close look at the construction and role of both products, as well as the characteristics of each. The biosimilar product should not have a clinically meaningful difference from the existing manufactured products for its following components:

  • Safety
  • Effectiveness
  • Purity
  • Potency
  • Chemical identity
  • Bioactivity

Minor differences between the two products may be included in their inactive components. Differences found are evaluated by the FDA. This helps ensure that the biosimilar product passes the rigorous standard of approval that the FDA holds on new clinical products. A biosimilar is allowed to be manufactured when the patent expires for the original biologic product.

Both biosimilars and generics can serve as a more affordable treatment option than the original brand-name formulation. Biosimilars, however, are not considered generic medications.