Follow along with this simple, animated white board video to learn about biosimilars, biologics, and how interchangeability can help to increase patient access while decreasing the cost of expensive medicines.
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A biosimilar is an FDA-approved biologic medicine that is highly similar to a previously approved biologic medicine. Biosimilars are clinically equivalent to their reference medicines which means that they are just as safe and effective and have no clinically meaningful differences. Biosimilar medicines are often available at a lower cost than the previously approved biologic medicine they reference.Approved biosimilars can be used to treat patients with conditions such as Crohn’s disease, ulcerative colitis, psoriasis, and cancer. Like all biologic medicines, a doctor prescribes a biosimilar to a patient. An interchangeable biologic is a biosimilar medicine as outlined by law for which additional data is provided to show that one can go back and forth multiple times between the biosimilar and reference medicine without a loss of efficacy or a safety concern. Biosimilar medicines are approved with the expectation to have the same clinical outcomes as the reference product at a population level; interchangeable biologics are required to demonstrate this at an individual level. Like a generic drug, a pharmacist may substitute an interchangeable biologic for an already prescribed reference biologic unless otherwise indicated by the prescribing physician, as the interchangeable is expected to produce the same result as the reference biologic in any given patient. Physicians always have the ability to specify that the pharmacist must dispense only the drug specified on the prescription. It is important to understand that an interchangeable biologic is not superior in quality, safety or effectiveness to a biosimilar product. An interchangeable biologic is a biosimilar medicine that has submitted additional information to as both have to meet the very same high standards. Patients and health care professionals can rely upon the safety and effectiveness of the biosimilar or interchangeable biologic, just as they would the reference medicine.