According to the FDA, a biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.
How Do We Fix This?
Biosimilars and Cancer
10K
6/10
$10 BN
Biosimilars represent an opportunity for significant savings for cancer care
Streamlining Regulation
Biosimilars and interchangeable products meet the FDA’s high standard for approval. These standards should assure health care providers that they can be confident in the safety and effectiveness of biosimilars and interchangeable product, just as they would be for an FDA-approved reference product.