by Amanda Conschafter, blog editor
As “A Prescription for Safe Biologics” explains, regulators must prioritize patient safety by ensuring that distinct names differentiate biosimilars from biologics. Equally important, the FDA should require comprehensive testing – not employ regulatory shortcuts – to prove biosimilars’ safety and efficacy for each FDA-approved indication.
Video host and AfPA Chairman David Charles, MD explains that:
- Distinct nonproprietary names for biosimilars maintain clarity and protect patients.
With distinct names, physicians and patients can be certain which medication a patient is taking. That clarity allows them to monitor side effects and to report adverse events accurately.
- Testing for each approved indication safeguards patients’ well-being.
Biosimilars introduce the risk of indication extrapolation, a shortcut whereby regulators apply approved indications of the brand-name medication to the biosimilar – even if the biosimilar has not been tested for these indications. Only by testing for each indication can regulators safely approve medications this complex and powerful.
The FDA now has under consideration multiple applications for biosimilar medications. Before these therapies enter the market for the first time in 2015, regulators must address crucial issues of patient safety.
Watch “A Prescription for Safe Biologics ” to learn more about how biosimilar naming and testing affect patient safety.