FDA issues guidance on naming biological products
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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FDA has released a draft guidance that details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draft guidance proposes that "reference products and biosimilars have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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