A biosimilar is a type of biologic medication. Biologics are medicines made from living organisms that have had a major impact on the treatment of many medical conditions, including inflammatory bowel disease (IBD).
What are biosimilars?
Biosimilars are developed to be highly similar, but not identical to a biologic in the market that is already FDA-approved. The original biologic against which the biosimilar is evaluated is often referred to as the “reference product.”
FDA Approval Process
The process to make a biosimilar is very complex, and the U.S. Congress has created a unique process for biosimilars’ approval. For a biosimilar to be approved by the FDA, it must meet strict requirements to show that it works the same way as the reference product, and produces no meaningful clinical differences in terms of safety and effectiveness from the reference product. It must also have the same mechanism of action, route of administration, dosage form and strength as the reference product.
Many biologics have come off patent or will soon come off patent. This has provided drug manufacturers with the incentive and opportunity to develop biosimilars to compete with existing biologics. As the market for biologics and biosimilars grows, having new products available will benefit health-care providers and patients by increasing treatment options and improving access to important medicines at lower costs.