There are two new types of biological products- biosimilar and interchangeable.
- Biosimilars are a type of biological product that are licensed (approved) by FDA because they are highly similar to an already FDA-approved biological product, known as the biological reference product (reference product), and have been shown to have no clinically meaningful differences from the reference product.
- An interchangeable biological product, in addition to meeting the biosimilarity standard, is expected to produce the same clinical result as the reference product in any given patient.
The FDA will only approve a biosimilar product if it has the same mechanism of action, route of administration, dosage form, and strength as the reference product. Additionally, a biosimilar can only be approved for the indications and conditions of use that have been previously approved for the reference product.