Biological Products Name Safety Testing
Are you developing a biological product or already have one on the market in the US? Do you know the proper naming convention for its non-proprietary name? Whether you already have a biological product on the market or are developing a new product, a related product or a biosimilar, there is a new guidance for developing the non-proprietary name. Click here for new FDA guidelines.
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.”
This guidance will apply to originator biological products, related biological products, biosimilar products and interchangeable biological products.
Med-ERRS can evaluate your non-proprietary name with the 4-letter suffix to ensure that it meets the guidance criteria, such as not being misleading or including abbreviations used in clinical practice, which could lead to rejection of the name.