Relationship Between Biosimilars and Biologics
Biosimilars are highly similar to their biologic reference product. All biologics, including biosimilars:
- Target specific parts of the immune system rather than impacting the entire immune system
- Are given as an injection or IV infusion
To be approved as a biosimilar for a particular reference biologic, the biosimilar must be:
- Highly similar to the reference product and cannot have any clinically meaningful differences in terms of safety or efficacy
- Approved for the indication(s) and condition(s) for which the reference product is approved
- Be given the same form and in the same dosage as the reference product
Keep in mind that biosimilars are not exact copies of their biologic reference product. Biologics are large and complex molecules from living sources that cannot be exactly copied.