By Amanda Conschafter, blog editor
The Food and Drug Administration’s approval process ensures safety and efficacy for each medical therapy and each indication approved. Or does it? In a new policy brief, the Institute for Patient Access explores how a regulatory shortcut known as “indication extrapolation” could impact patient safety if used with biological medicines. The issue proves timely; the FDA’s current consideration of two applications for biosimilar approval will likely include a decision on whether to employ the shortcut for these medications.
As policy brief authors David Charles, M.D. and Mary Ann Chapman, Ph.D. explain, indication extrapolation acts as a substitute for full clinical testing on each indication, or use, for which a biosimilar receives approval. Through the established regulatory process, a biosimilar first achieves approval for one or two of its innovator product’s indications after standard clinical testing. But regulators may then make a leap of logic. They may approve the biosimilar for more of the innovator product’s indications – without clinical testing for these additional indications.
Extrapolating indications from one therapy to another poses a risk to patient safety, the policy brief argues, particularly for complex biological medications. These therapies’ sophisticated molecular structures and multiple mechanisms of action generate unique effects for patients – and impact patients’ immune systems to varying degrees. If regulators opt to assume that a biologic and its biosimilar imitation will provide identical results for patients, they should do so with caution and forethought.
Read “What is Indication Extrapolation and Should it Be Allowed with Biological Medicines?” in full to learn more about indication extrapolation, the unique properties of biological medicines, and how regulators in Canada and the European Union have addressed this issue.