The U.S. Food and Drug Administration released its final guidance on naming biologics and biosimilars.
The requirement was designed with the hope to easily categorize a drug and any subsequent variations that use the same base, and avoid any confusion. The guidance helps to codify names for new drugs set to be released or under development, and gives stakeholders a template from which to prepare for their approvals.
One of the new requirements in the elimination of a proper names of developing drugs, and the implementation of a core name for both biologics and biosimilars, is the attachment of a four-letter suffix.
Pharmaceutical companies have to use the new guidance by 2020, giving them three years to rename existing products.
FDA issues new naming guidance for biologics, biosimilars
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