Biological Products Name Safety Testing


Med-ERRS performs biological product name testing on non-proprietary names with the 4-letter suffix to ensure it meets the FDA guidance criteria which could lead to name rejection. This guidance will apply to originator biological products, related biological products, and interchangeable biological products.

The FDA released a guidance in January 2017 providing sponsors with information regarding a requirement for application of a four-letter suffix to its non-proprietary name for biological products. This will include biological products already on the market. As part of the guidance, FDA encourages applicants who are trying to get their biological product approved to conduct “due diligence on their proposed suffixes to ensure that it will meet the recommendations in its guidance.”