Wednesday 14 October 2015

FDA issues guidance on naming biological products

The FDA has released a draft guidance that details the agency's proposal on the nonproprietary naming of biological products, according to a recent blog post on FDA Voice.

The draft guidance proposes that "reference products and biosimilars have nonproprietary names that share a core drug substance name and, in order to better identify each product, an FDA-designated suffix that is unique for each product. This suffix would be composed of four lowercase letters, and not carry any meaning."

Posted by Tim Sandle

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