Earlier this week the US Food and Drug Administration (FDA) Approved a Biologics License Application (BLA) for bevacizumab-maly, a biosimilar referencing Avastin (bevacizumab). This is the third biosimilar of bevacizumab approved in the US.
A biosimilar is a medication that is almost identical to another medication. The approval of biosimilar products is regulated by the 2010 Biologics Price Competition and Innovation Act (BPCI). Under this legislation, the biosimilar must be shown to be “highly similar to the reference product in structure and function notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” The reference product is a therapy that has been approved by the FDA after completion of the full approval and review process including clinical trial data demonstrating safety and efficacy.
A subset of biosimilars known as interchangeable products are biosimilars that have been shown to produce the same clinical result as the reference product in any given patient. Studies must be conducted that verify the safety and sustained efficacy, of alternating or switching between the reference product and the interchangeable product.
Biosimilars are sometimes confused with generic medications. A generic medication is an identical copy of an approved medication. Generic medications usually undergo therapeutic equivalence studies. Both the original medication and the generic version will share the same safety and efficacy profiles. An example of a generic medication would be the store brand of aspirin versus the branded St. Josephs or Bayer Aspirin variety.
A term that is often used interchangeably with biosimilars, but has a slightly different meaning, is “bio-better”. This term is used to describe a therapeutic whose active ingredient or formulation has been modified in some way to improve efficacy or safety.
The bottom line is that biosimilars are safe and effective and have been reviewed and approved by the FDA.
If you would like to learn more about biosimilars, please click here
A list of FDA approved biosimilars may be found here.
For healthcare provider materials about biosimilars please click here.
For patient materials about biosimilars please click here.
Photo by Anna Shvets,